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Background: Preoperative computed tomography (CT) measurements of glenoid version and inclination are recommended for planning glenoid implantation in shoulder arthroplasty. However, current manual or semi-automated 2-dimensional (2D) and 3-dimensional (3D) methods are user-dependent and time-consuming. We assessed whether the use of a 3D automated method is accurate and reliable to measure glenoid version and inclination in osteoarthritic shoulders., Methods: CT scans of osteoarthritic shoulders of 60 patients scheduled for shoulder arthroplasty were obtained. Automated, surgeon-operated, image analysis software (Glenosys; Imascap) was developed to measure glenoid version and inclination. The anatomic scapular reference planes were defined as the mean of the peripheral points of the scapular body as well as the plane perpendicular to it, passing along the supraspinatus fossa line. Measurements were compared with those obtained using previously described manual or semi-automated methods, including the Friedman version angle on 2D CTs, Friedman method on 3D multiplanar reconstructions (corrected Friedman method), Ganapathi-Iannotti and Lewis-Armstrong methods on 3D volumetric reconstructions (for glenoid version), and Maurer method (for glenoid inclination).The mean differences (and standard deviation) and the concordance correlation coefficients (CCCs) were calculated. Two orthopaedic surgeons independently examined the images for the interobserver analysis, with one of them measuring them twice more for the intraobserver analysis; interobserver and intraobserver reliability was calculated using the intraclass correlation coefficients (ICCs)., Results: The mean difference in the Glenosys glenoid version measurement was 2.0° ± 4.5° (CCC = 0.93) compared with the Friedman method, 2.5° ± 3.2° (CCC = 0.95) compared with the corrected Friedman method, 1.5° ± 4.5° (CCC = 0.94) compared with the Ganapathi-Iannotti method, and 1.8° ± 3.8° (CCC = 0.95) compared with the Lewis-Armstrong method. There was a mean difference of 0.2° ± 4.7° (CCC = 0.78) between the inclination measurements made with the Glenosys and Maurer methods. The difference between the overall average 2D and 3D measurements was not significant (p = 0.45)., Conclusions: Use of fully automated software for 3D measurement of glenoid version and inclination in arthritic shoulders is reliable and accurate, showing excellent correlation with previously described manual or semi-automated methods., Clinical Relevance: The use of automated surgeon-operated image analysis software to evaluate 3D glenoid anatomy eliminates interobserver and intraobserver discrepancies, improves the accuracy of preoperative planning for shoulder replacement, and offers a potential gain of time for the surgeon.

Background: The feasibility, safety, and efficacy of programs for enhanced recovery after bariatric surgery (ERABS) are now well established. However, data concerning their large-scale implementation remain insufficient., Objectives: The objective of the present study was to review the multicenter implementation of ERABS SETTING: This retrospective analysis of a prospective database was conducted in 15 Groupe francophone de Rehabilitation Améliorée après ChirurgiE centers from data from March 2014 to January 2017., Methods: The Francophone working Group for Enhanced Recovery After Surgery (Groupe francophone de Rehabilitation Améliorée après ChirurgiE) edited and released protocols of ERABS for its members. Compliance with ERABS, lengths of hospital stay, and postoperative morbidity were obtained from the Groupe francophone de Rehabilitation Améliorée après ChirurgiE-audit database., Results: In this study, 1667 patients were included. Procedures were sleeve gastrectomy (n = 1011), gastric bypass (n = 300), or mini-bypass (n = 356). Mean body mass index was 41.8 ± 8.3 kg/m 2 . Global morbidity was 2.57%, and surgery-related morbidity was 1.67% (mostly anastomotic leakages and hemorrhage). Mean length of hospital stay was 2.4 ± 3.6 days. Overall compliance was 79.6%. Among the 23 elements of the ERABS program, 14 were applied in>70% of instances, 6 in between 50% and 70%, and 3 in<50%. The elements least often applied were limb intermittent pneumatic compression during surgery (23.3%), multimodal analgesia (49.5%), and optimal perioperative fluid management (43.8%)., Conclusion: This study shows that even if the overall compliance was good, the large-scale implementation of ERABS can still be improved, as several elements remain insufficiently applied. This finding highlights the importance of thorough, continuous training in addition to the need for repeated audits by centers involved in ERABS programs., (Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Fatty infiltration (FI) compromises outcomes of rotator cuff repairs. Most clinicians consider FI of the infraspinatus, whether it is torn or intact, because it is most rapidly affected. The purpose of this study was to report long-term outcomes of isolated supraspinatus repairs and to determine their associations with FI of the infraspinatus and supraspinatus., Methods: The records of 182 patients who underwent repair of isolated supraspinatus tears and had preoperative magnetic resonance imaging were retrieved. Of these, 147 patients were evaluated at 10 years' follow-up using the Constant score and magnetic resonance imaging scans., Results: Preoperative FI was greater in the supraspinatus (52% stage ≥1) than in the infraspinatus (29% stage ≥1). The 10-year Constant scores were influenced by FI of the supraspinatus (P = .006) but not of the infraspinatus (P = .422). Multivariable regression confirmed that Constant scores were significantly lower for female patients, repetitive work, and stage 1 and stage 2 FI of the supraspinatus in addition to open surgery. Retear rates (Sugaya types IV-V) were also influenced by FI of the supraspinatus (P = .001) but not of the infraspinatus (P = .979). Shoulders with supraspinatus FI at stages 0, 1, and 2 had retear rates of 10%, 22%, and 31%, respectively. Multivariable regression affirmed that the odds of retears are significantly increased by both stage 1 and stage 2 FI of the supraspinatus., Conclusions: The Constant scores and retear rates were significantly associated with FI of the torn supraspinatus (stage ≥1) but not of the intact infraspinatus. The authors recommend that rapid surgical intervention be considered, before accumulation of fat, especially for young, active patients., (Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Anterosuperior rotator cuff tears are more frequent than expected. We report the results of a 10-year follow-up study after repair. Our hypothesis was that the extent of the subscapularis tear influenced the prognosis., Materials and Methods: The study population consisted of all 138 patients who underwent surgery in 14 participating centers in 2003 for full-thickness tears of the rotator cuff with lesions in the subscapularis and supraspinatus tendons. The patients were divided into 2 groups, depending on whether the subscapularis lesion affected only the superior half of the tendon (group A) or extended into the lower half (group B). Ninety-two patients (56 ± 7 years; 71 in group A and 21 in group B) were available for follow-up after 10 years (127 ± 16 months) with magnetic resonance imaging to evaluate tendon healing and muscle condition., Results: The mean Constant scores were 59 ± 16 before surgery and 77 ± 14 at follow-up (P = 1.7 × 10 -12 ). The retear rates were 25% for the supraspinatus and 13.5% for the subscapularis tendon. The clinical results for group A patients were better than those for group B. Severe fatty infiltration was observed more frequently in the subscapularis than in the supraspinatus muscle (27% vs. 12% of cases). Supraspinatus healing influenced subscapularis healing and fatty infiltration., Conclusions: Repair of anterosuperior rotator cuff tears is satisfactory at 10 years, particularly if the subscapularis tear is not extensive. An extensive subscapularis tear is a negative prognosis factor. Postoperatively, fatty infiltration of the subscapularis muscle was frequently observed despite tendon healing., (Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis., Methods: Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n = 23) or clinical (n = 6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values was used., Results: A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean ± SD) for recognizing the characteristic image pattern of SCA were κ = 0.83 (almost perfect); 95% CI, 0.73-0.92; and κ = 0.85 ± 0.11 (almost perfect), respectively., Conclusions: EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE. (Clinical trial registration number: NCT02516488.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Study Aims:  The low sensitivity of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), especially for the diagnosis of serous cystadenomas (SCAs), can be associated with diagnostic uncertainty that can regularly lead to unnecessary surgical procedures. Needle-based confocal laser endomicroscopy (nCLE) used with EUS-FNA improves diagnostic accuracy, helping to reduce unnecessary surgery and patient follow-up. This study was conducted to evaluate the economic benefit of EUS-FNA + nCLE., Patients and Methods:  Probabilities used were derived from two studies representative of the two diagnostic strategies: a retrospective analysis of patients diagnosed by EUS-FNA alone and a prospective study of patients diagnosed by EUS-FNA + nCLE. Costs were based on French healthcare system rates; both private and public sector rates were included. A decision tree structure model used these probabilities and costs for two hypothetical cohorts of 1000 patients., Results:  EUS-FNA + nCLE resulted in a reduction of 23 % in the total rate of surgical intervention, which translated to a reduction in clinical costs of 13 % (public sector) and 14 % (private sector). Additionally, the reduced rate of surgery would save the lives of 4 in 1000 patients. A stochastic sensitivity analysis using 100 simulations showed that in all cases the number of interventions was less for EUS-FNA + nCLE than for EUS-FNA. There was also a reduction in the incidence of false negatives using EUS-FNA + nCLE., Conclusions:  EUS-FNA + nCLE results in significant economic benefits by reducing the incidence of misdiagnosis through improved diagnostic accuracy.

Background: Early clinical results of anterolateral ligament (ALL) reconstruction are promising, but concerns exist due to high rates of complications after other types of lateral extra-articular tenodesis. The rate of surgery after combined anterior cruciate ligament (ACL) and ALL reconstruction is not known., Purpose: To determine the rate of reoperation after combined ACL and ALL reconstruction., Study Design: Case series; Level of evidence, 4., Methods: A retrospective analysis of prospectively collected data from the Scientific ACL Network International (SANTI) Study Group database was performed to include all patients who had undergone combined ACL and ALL reconstruction between January 2012 and June 2014. At the end of the study period, all patients were contacted by telephone, and the operative notes of those who stated that they had undergone reoperation were reviewed to determine the type and rates of the subsequent procedures performed. Descriptive data were analyzed for the entire patient cohort., Results: The study population comprised 548 quadruple hamstring graft (4HT)+ALL reconstructions. The mean age (±SD) was 24.3 ± 7.9 years (range, 11.9-55.7 years), and 70.3% of subjects were male. The mean duration of follow-up was 35.5 ± 8.0 months (range, 24-54 months). Seventy-two patients (13.1%) underwent ipsilateral reoperation. This comprised a total of 77 procedures. Graft revision occurred in 14 knees (2.6%) at a mean of 18.3 months (±7.4 months) after the index procedure. There were 63 reoperations for ipsilateral, non-graft rupture-related indications (meniscus, n = 30; arthrofibrosis, n = 22; removal of hardware, n = 4; deep infection, n = 3; arthroscopic lavage without infection, n = 4). The only specific complications related to the ALL procedure (n = 3) were all related to femoral hardware that required removal. In both univariate and multivariate analyses, only the presence of a medial meniscal lesion at the index procedure was significantly associated with ipsilateral reoperation (odds ratio, 2.58; 95% CI, 1.43-4.76; P = .002)., Conclusion: The reoperation rate after combined ACL and ALL reconstruction in this series is broadly comparable to the reoperation rate after isolated ACL reconstruction as reported in previous studies. In addition, the high rates of knee stiffness and reoperation reported in historical series of nonanatomic, lateral extra-articular tenodesis were not observed in the current series.

Background: The squamous cell carcinoma of the anus (SCCA) is a rare disease, but its incidence is markedly increasing. About 15% of patients are diagnosed at metastatic stage, and more than 20% with a localized disease treated by chemoradiotherapy (CRT) will recur. In advanced SCCA, cisplatin and 5-fluorouracil (CF) combination is the standard option but complete response is a rare event and the prognosis remains poor with most disease progression occurring within the first 12 months. We have previously published the potential role of the addition of docetaxel (D). Among 8 consecutive patients with advanced recurrent SCCA after CRT, the DCF regimen induced a complete response in 4 patients, including 3 pathological complete responses. Then, the Epitopes-HPV02 study was designed to confirm the interest of DCF regimen in SCCA patients., Methods: This multicentre phase II trial assesses the DCF regimen in advanced SCCA patients. Main eligibility criteria are: histologically proven SCCA, unresectable locally advanced recurrent or metastatic disease, Eastern Cooperative Oncology Group-performance status (ECOG-PS) <2, and being eligible for DCF. Patients receive either 6 cycles of standard DCF or 8 cycles of modified DCF depending on age (> vs. ≤ 75 years-old) and ECOG-PS (0 vs. 1). The trial was set up based on a Simon's optimal two-stage design for phase II trials, allowing an early futility interim analysis. The primary endpoint is the observed progression-free survival (PFS) rate at 12 months from the first DCF cycle. A PFS rate below 10% is considered uninteresting, while a PFS rate above 25% is expected. With a unilateral alpha error of 5% and a statistical power of 90%, 66 evaluable patients should be included. Main secondary endpoints are overall survival, PFS, response rate, safety, health-related quality of life, and the correlation of biomarkers with treatment efficacy., Discussion: Since the recommended CF regimen is based in a small retrospective analysis and generates a low rate of complete responses, the Epitopes-HPV02 study will establish a new standard in case of a positive result. Associated biomarker studies will contribute to understand the underlying mechanism of resistance and the role of immunity in SCCA., Trial Registration: NCT02402842 , EudraCT: 2014-001789-81.

Objective: To determine the incidence and MRI characteristics of the spectrum of posterolateral corner (PLC) injuries occurring in association with anterior cruciate ligament (ACL) rupture., Materials and Methods: We carried out a level IV, retrospective case series study. All patients clinically diagnosed with an ACL rupture between July 2015 and June 2016 who underwent MRI of the knee were included in the study. In addition to standard MRI knee reporting, emphasis was placed on identifying injury to the PLC and a description of involvement of these structures by two musculoskeletal radiologists. Association with PLC involvement was sought with concomitant injuries using correlation analysis and logistic regression., Results: One hundred sixty-two patients with MRI following ACL rupture were evaluated. Thirty-two patients (19.7%) had an injury to at least one structure of the PLC, including the inferior popliteomeniscal fascicle (n = 28), arcuate ligament (n = 20), popliteus tendon (n = 20), superior popliteomeniscal fascicle (n = 18), lateral collateral ligament (n = 8), popliteofibular ligament (n = 7), biceps tendon (n = 4), iliotibial band (n = 3), and fabellofibular ligament (n = 1). Seventy-five percent of all patients with combined ACL and PLC injuries had bone contusions involving the lateral compartment of the knee. The presence of these contusions strongly correlated with superior popliteomeniscal fascicle lesions (p < 0.05). There was no correlation between injuries to other structures of the PLC and other intra-articular lesions., Conclusion: Missed injuries of the PLC lead to considerable morbidity. The relevance of this study is to highlight that these injuries occur more frequently than previously described and that an appropriate index of suspicion, clinical examination, and MRI are all required to reduce the risk of missed diagnoses. The results of this study support previous suggestions that the rate of concomitant PLC injury in the ACL-deficient knee is under-reported. The rate of combined injuries in this series was 19.7%. The key message of this paper is that PLC injury is common in the presence of ACL injury and should be sought both clinically and radiologically.

Purpose: To evaluate the clinical and functional outcome following the reconstruction of chronic patellar tendon ruptures using the contralateral bone-tendon-bone (BTB) autograft., Methods: The records of seven patients who underwent reconstruction of chronic patellar tendon rupture with contralateral patellar BTB were retrospectively reviewed. Chronic tears were defined as a minimum of 3 months from injury to initial clinical evaluation. Clinical assessments included range of motion of the knee, Tegner, Lysholm and International Knee Documentation Committee (IKDC) score and a radiographic analysis of patellar height (Caton-Deschamps index). Postoperative complications and quadriceps strength at last follow-up were reported., Results: The mean age of the patients undergoing surgery was 33 (±10.5) years with a mean follow-up of 41.3 (±29.7) months. Reconstruction surgery was performed at an average of 16 months (3-60 months) after the injury. 86 % of the patients had a normal patella height with mean of patellar height of 1.5 (±0.2) in preoperative radiographs and of 1.2 (±0.07) on postoperative evaluation (p = 0.0136). The mean IKDC was 45.5 (±10.8) before surgery and 64.5 (±12.4) at the last follow-up (p = 0.0001), and Lysholm score was 45.4 (±11.3) and 79 (±11.8), respectively (p = 0.0001). The median Tegner activity scale preinjury was 6 (range 5-7), preoperatively was 1 (range 1-2) and 4 (range 2-5) postoperatively (p = 0.0001). All patients had quadriceps wasting with a difference in thigh girth between the injured side and healthy side of 3.6 ± 0.7 cm (ns). No surgical complications were encountered., Conclusions: In this limited cohort, surgical reconstruction of chronic patellar tendon ruptures using contralateral bone-tendon-bone graft was a safe and viable option that improves clinical and functional outcomes compared to presurgical function. However, despite the restoration of a normal patellar height, function did not return to preinjury level.

Background: Graft failure and low rates of return to sport are major concerns after anterior cruciate ligament (ACL) reconstruction, particularly in a population at risk., Purpose: To evaluate the association between reconstruction techniques and subsequent graft rupture and return-to-sport rates in patients aged 16 to 30 years participating in pivoting sports., Study Design: Cohort study; Level of evidence, 2., Methods: A prospective study of patients undergoing primary ACL reconstruction with a bone-patellar tendon-bone (B-PT-B) graft, quadrupled hamstring tendon (4HT) graft, or hamstring tendon graft combined with anterolateral ligament reconstruction (HT+ALL) was conducted by the Scientific ACL NeTwork International (SANTI) Study Group. Survivorship data from Kaplan-Meier analysis were analyzed in multivariate Cox regression models to identify the prognosticators of graft ruptures and return to sport., Results: Five hundred two patients (mean age, 22.4 ± 4.0 years) with a mean follow-up of 38.4 ± 8.5 months (range, 24-54 months) were included. There were 105 B-PT-B, 176 4HT, and 221 HT+ALL grafts. The mean postoperative scores at latest follow-up were the following: Lysholm: 92.4 ± 8.6, Tegner: 7.4 ± 2.1, and subjective International Knee Documentation Committee (IKDC): 86.8 ± 10.5 for B-PT-B grafts; Lysholm: 91.3 ± 9.9, Tegner: 6.6 ± 1.8, and subjective IKDC: 85.4 ± 10.4 for 4HT grafts; and Lysholm: 91.9 ± 10.2, Tegner: 7.0 ± 2.0, and subjective IKDC: 81.8 ± 13.1 for HT+ALL grafts. The mean side-to-side laxity was 0.6 ± 0.9 mm for B-PT-B grafts, 0.6 ± 1.0 mm for 4HT grafts, and 0.5 ± 0.8 mm for HT+ALL grafts. At a mean follow-up of 38.4 months, the graft rupture rates were 10.77% (range, 6.60%-17.32%) for 4HT grafts, 16.77% (range, 9.99%-27.40%) for B-PT-B grafts, and 4.13% (range, 2.17%-7.80%) for HT+ALL grafts. The rate of graft failure with HT+ALL grafts was 2.5 times less than with B-PT-B grafts (hazard ratio [HR], 0.393; 95% CI, 0.153-0.953) and 3.1 times less than with 4HT grafts (HR, 0.327; 95% CI, 0.130-0.758). There was no significant difference in the graft failure rate between 4HT and B-PT-B grafts (HR, 1.204; 95% CI, 0.555-2.663). Other prognosticators of graft failure included age ≤25 years ( P = .012) and a preoperative side-to-side laxity >7 mm ( P = .018). The HT+ALL graft was associated with higher odds of returning to preinjury levels of sport than the 4HT graft (odds ratio [OR], 1.938; 95% CI, 1.174-3.224) but not compared with the B-PT-B graft (OR, 1.460; 95% CI, 0.813-2.613)., Conclusion: In a high-risk population of young patients participating in pivoting sports, the rate of graft failure with HT+ALL grafts was 2.5 times less than with B-PT-B grafts and 3.1 times less than with 4HT grafts. The HT+ALL graft is also associated with greater odds of returning to preinjury levels of sport when compared with the 4HT graft.

Background: Remnant preservation may confer important advantages in the anterior cruciate ligament (ACL)-reconstructed knee. However, the presence of a large remnant may obscure visualization and impair the ability to correctly place tunnels during surgery., Purpose: To determine whether tunnel placement during anatomic ACL reconstruction using the single anteromedial bundle biological augmentation (SAMBBA) technique is consistent and precise when a large native remnant is preserved., Study Design: Case series; Level of evidence, 4., Methods: Included in this study were 99 patients undergoing an ACL reconstruction during which at least 50% of the native ACL was preserved. The femoral tunnel was created using an outside-in specific guide. The tibial tunnel was positioned in the anteromedial region of the ACL footprint, and the remnant was carefully preserved while drilling and passing the semitendinosus graft through it. Postoperatively, 3-dimensional computed tomography (3D CT) was used to evaluate tunnel placement. The mean tunnel locations were calculated and the standard deviation was used to evaluate precision of positioning. Inter- and intrareader agreement were determined to assess reliability of evaluation of tunnel position., Results: The center of the femoral tunnel was positioned at a mean 19.4% (SD, 2%) of the depth of the notch and a mean 23.1% (SD, 3.5%) of the lateral wall height. The center of the tibial tunnel was positioned at a mean 36.3% (SD, 3.8%) of the anteroposterior length of the tibial plateau and at a mean 47.0% (SD, 2.7%) of the mediolateral width. The small standard deviations demonstrate that this technique allows precise tunnel placement. The tunnel positions achieved were consistent with previous anatomic studies of femoral and tibial anteromedial bundle insertion. Intra- and interobserver reliability were high., Conclusion: Three-dimensional CT evaluation demonstrated that despite the presence of a large remnant, placement of femoral and tibial tunnels for anatomic ACL reconstruction using the SAMBBA technique is consistent and precise., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: B.S.-C. receives royalties from, is a paid consultant for, receives research support from, and has made presentations for Arthrex. M.T. is a paid consultant for, receives research support from, and has made presentations for Arthrex.

Background: Nab-paclitaxel plus gemcitabine has become a standard treatment regimen in patients with metastatic pancreatic adenocarcinoma; however, retrospective data suggest that gemcitabine might be inefficient in 50-60% of patients and thus not an optimum regimen in combination with nab-paclitaxel. We did a phase 2 trial to assess the activity and safety of a new regimen of nab-paclitaxel plus simplified leucovorin and fluorouracil., Methods: We did a non-comparative, multicentre, open-label, randomised phase 2 trial in 15 hospitals and institutions in France. Eligible participants were previously untreated patients with metastatic pancreatic adenocarcinoma (previous adjuvant chemotherapy after curative intent resection was allowed if the interval between the end of chemotherapy and relapse was more than 12 months). Patients had to have at least one measurable lesion assessed by CT scan or MRI and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. We randomly assigned participants (1:2) centrally to 28-day cycles of either gemcitabine plus nab-paclitaxel or simplified leucovorin and fluorouracil plus nab-paclitaxel. The randomisation was by minimisation, stratified by centre and ECOG performance status. Drugs were administered in each cycle as follows: nab-paclitaxel (125 mg/m 2 ) and gemcitabine (1000 mg/m 2 ) as 30-min intravenous infusions on days 1, 8, and 15; leucovorin (400 mg/m 2 ) as a 120-min intravenous infusion on days 1 and 15; and fluorouracil (400 mg/m 2 ) as a 5-min bolus intravenous infusion followed by a 46-h continuous intravenous infusion of 2400 mg/m 2 on days 1 and 15. Patients continued treatment until unacceptable toxicity, disease progression, or patient withdrawal. The primary endpoint was progression-free survival at 4 months in the first 72 assessable patients in the leucovorin and fluorouracil group, with a target of 50% for the regimen to be deemed sufficiently active to warrant further study. We did the primary analysis on the modified intention-to-treat (ITT) population, defined as all randomly assigned and assessable patients regardless of their eligibility and received treatments. This trial is registered at ClinicalTrials.gov, number NCT01964534. The trial has ended and we report the final analysis here., Findings: Between Dec 12, 2013, and Oct 31, 2014, we randomly assigned 114 patients to treatment: 75 patients to the leucovorin and fluorouracil group and 39 to the gemcitabine group. One patient in the leucovorin and fluorouracil group did not have a 4-month assessment, and was thus excluded from the modified ITT analysis. Median follow-up was 13·1 months (95% CI 12·5-14·1). At 4 months, 40 (56%, 90% CI 45-66) of 72 patients in the leucovorin and fluorouracil group were alive and free from disease progression (21 [54%, 40-68] of 39 patients in the gemcitabine group were also alive and progression-free at 4 months). Grade 3-4 adverse events occurred in 33 (87%) of 38 patients in the gemcitabine group and in 56 (77%) of 73 patients in the leucovorin and fluorouracil group, with different toxicity profiles. The most common grade 3-4 adverse events in the leucovorin and fluorouracil group were neutropenia without fever (17 [23%]), fatigue (16 [22%]), paraesthesia (14 [19%]), diarrhoea (nine [12%]), and mucositis (seven [10%]); in the gemcitabine group they were neutropenia without fever (12 [32%]), thrombocytopenia (seven [18%]), fatigue (eight [21%]), anaemia (five [13%]), increased alanine aminotransferase and aspartate aminotransferase concentrations (five [13%] for both), and paraesthesia (four [11%]). Two participants died; one in the leucovorin and fluorouracil group from septic shock, and one in the gemcitabine group from diabetes compensation with acidosis; these deaths were deemed to be not related to treatment. Treatment-related serious adverse events occurred in 28 (38%) of 73 patients in the leucovorin and fluorouracil group and in 14 (37%) of 38 in the gemcitabine group., Interpretation: Nab-paclitaxel plus simplified leucovorin and fluorouracil fulfilled the primary endpoint in that more than the required 50% of our study population were progression-free at 4 months, with a tolerable toxicity profile. This regimen thus deserves further assessment in a phase 3 trial., Funding: GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) and Celgene through grants to GERCOR., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: The therapeutic role of endoscopic papillectomy (EP) for early ampullary cancer (AC) is still controversial. The aim of the present study was to evaluate the curative potential of EP for early AC and to identify predictors of lymph node metastases (LNMs)., Methods: We retrospectively reviewed 173 patients who were prospectively included in a database and who underwent EP between 1999 and 2013. Adenocarcinoma was present in 28 resected specimens. An additional surgery was proposed in cases of duodenal submucosal infiltration, duct ingrowth, R1 resection or lymphovascular invasion. Clinicopathological information and outcomes were collected, and predictors of LNMs were evaluated., Results: Duodenal submucosal invasion was present in 16/28 cases and LNMs, in 9/28 cases. ACs of the biliopancreatic subtype were smaller (NS); 100 % had submucosal invasion, and 71 % had LNMs. Smaller tumour size, biliopancreatic subtype and submucosal invasion were significantly correlated with LNMs (p < 0.028, p < 0.028 and p < 0.014). Predictive factors of LNMs in the multivariate analysis were submucosal invasion and tumour size (OR 0.032, p < 0.023 and OR 0.711, p < 0.035). EP was curative in 100 % of cancers with R0 resection and no evidence of submucosal or lymphovascular invasion., Conclusion: EP may be curative for patients with AC limited to the duodenal mucosa or the sphincter of Oddi without lymphovascular invasion. Due to the presence of more invasive stages at diagnosis, EP may not be curative for ACs of the biliopancreatic subtype. The significance of tumour size is limited by other confounders, such as the histological subtype.

Background and Hypothesis: The Latarjet procedure has been shown to be a reliable method to prevent recurrent anterior shoulder instability. Coracoid bone graft osteolysis is a potential catastrophic complication and can lead to recurrent instability. The purpose of our study is to present a novel quantitative method to measure the amount of coracoid bone osteolysis using 3-dimensional (3D) computed tomography (CT) scan imaging., Materials and Methods: This is a prospective study with 15 patients (16 shoulders) who underwent an arthroscopic Latarjet procedure. Three-dimensional CT scans were obtained at 6 weeks and 6 months. Using volumetric analysis, we quantified the amount of bone loss using our described method. Interobserver reliability and intraobserver reliability were calculated., Results: On the basis of our new volumetric analysis of the arthroscopic Latarjet procedure using 3D CT scans, we found that the superior half of the coracoid bone graft undergoes a significant amount of osteolysis at 6 months postoperatively. The interobserver reliability and intraobserver reliability were excellent., Discussion: This study presents a reproducible method to quantify and compare coracoid bone graft osteolysis after an arthroscopic Latarjet procedure. We also developed a description system that may be used for comparison studies. To our knowledge, this is the first method that quantifies the amount of coracoid bone graft osteolysis using more accurate 3D CT scanning., Conclusion: The 3D analysis we propose is a valid method to measure the amount of coracoid bone graft osteolysis after an arthroscopic Latarjet procedure. Our description system may guide the surgeon regarding possible revision surgery when faced with significant osteolysis of the coracoid bone graft., (Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Cyclops syndrome is characterized by loss of terminal knee extension due to proliferative fibrous nodule formation in the intercondylar notch. This complication occurs in the early postoperative period after anterior cruciate ligament reconstruction (ACLR). The pathogenesis of Cyclops syndrome is not well understood., Hypothesis: Persistent hamstring contracture after ACLR is associated with an increased risk of subsequent Cyclops syndrome., Study Design: Case-control study; Level of evidence, 3., Methods: The files of 45 patients who underwent arthroscopic debridement of a Cyclops lesion after ACLR were analyzed. Recorded data included demographic information and technical details of surgery. Preoperative magnetic resonance images were also analyzed, and patients with femoral bone bruising were identified. Passive and active range of motion were recorded in all patients preoperatively and at 3 and 6 weeks after surgery to address the Cyclops lesion. Passive extension deficit was evaluated in comparison with the contralateral limb and classified as secondary to hamstring contracture when contracture was observed and palpated in the prone position and when the extension deficit was reversed after exercises performed to fatigue the hamstrings. A control group was selected using a random numbers table among our entire ACLR cohort. Statistical analysis was performed to analyze differences between the 2 groups., Results: There was no significant difference between the groups with regard to age at ACLR, sex distribution, time from injury to surgery ( P > .05), proportion of professional athletes, presence of femoral bone bruise, or technical aspects of surgery. The overall extension deficit incidence was significantly higher in the Cyclops group at 3 weeks (Cyclops, 71%; control, 22%) ( P < .001) and at 6 weeks (Cyclops, 60%; control, 7%) ( P < .001). The extension deficit related to hamstring contracture was significantly higher in the Cyclops group at 3 weeks (Cyclops, 58%; control, 22%) ( P < .001) and at 6 weeks (Cyclops, 29%; control, 2%) ( P < .001)., Conclusion: The Cyclops lesion is associated with a persistent hamstring contracture at 3 and 6 weeks after ACLR., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: B.S.C. is a paid consultant, receives royalties, receives research support, and has made presentations for Arthrex. M.T. is a paid consultant, receives research support, and has made presentations for Arthrex.

Background and Study Aims: The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal in centers that are not equipped with rapid on-site evaluation. Needle-based confocal laser endomicroscopy (nCLE) enables real-time in vivo microscopic imaging during endoscopy. This study aimed to describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the first validation of these criteria., Patients and Methods: A total of 40 patients were evaluated by EUS-FNA combined with nCLE for the diagnosis of pancreatic masses. Final diagnosis was based on EUS-FNA histology and follow-up at 1 year. Five unblinded examiners defined nCLE criteria for adenocarcinoma, chronic pancreatitis, and neuroendocrine tumor (NET) using a set of video sequences from 14 patients with confirmed pathology (Step 1). These criteria were retrospectively validated by four independent, blinded examiners using sequences from 32 patients (Step 2)., Results: nCLE criteria were described for adenocarcinoma (dark cell aggregates, irregular vessels with leakages of fluorescein), chronic pancreatitis (residual regular glandular pancreatic structures), and NET (black cell aggregates surrounded by vessels and fibrotic areas). These criteria correlated with the histological features of the corresponding lesions. In the validation review, a conclusive nCLE result was obtained in 75 % of cases (96 % correct). Statistical evaluation provided promising results, with high specificity, and negative and positive predictive values for all types of pancreatic masses., Conclusion: Considering the low negative predictive value of EUS-FNA, nCLE could help to rule out malignancy after a previous inconclusive EUS-FNA. Larger studies are required to confirm these findings and to establish the role of nCLE in the diagnosis of pancreatic masses., Trial Registration: ClinicalTrials.gov (NCT01563133)., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: To evaluate the rate of radiographic structural progression in the sacroiliac (SI) joints in patients with radiographic or nonradiographic axial spondyloarthritis (SpA), and to determine factors predisposing to such progression, over 2 years., Methods: Patients with recent-onset axial SpA (from the Devenir des Spondyloarthropathies Indifferérenciées Récentes cohort) were assigned a radiographic SI joint score according to the modified New York criteria. Demographic characteristics, smoking status, HLA-B27 positivity, inflammation on magnetic resonance imaging (MRI) of the SI joints, disease activity, and treatment were investigated as potential predisposing factors. The main analysis consisted of the evaluation of the switch from nonradiographic to radiographic axial SpA, but other definitions of radiographic progression were also evaluated., Results: Of the 708 patients enrolled, 449 had baseline and 2-year pelvic radiographs. Of these patients, 47% were men. Their mean ± SD age was 34 ± 9 years, 61% were B27 positive, and 37% had inflammation of the SI joints on MRI. The percentages of patients who switched from nonradiographic to radiographic axial SpA (4.9% [16 of 326]) and from radiographic to nonradiographic axial SpA (5.7% [7 of 123]) were low. The mean ± SD change in the total SI joint score (range 0-8) was small (0.1 ± 0.8) but highly significant (P < 0.001). The potential baseline predisposing factors for meeting the modified New York criteria in the multivariate analysis were current smoking, HLA-B27 positivity, and inflammation of the SI joints on MRI, with odds ratios of 3.3 (95% confidence interval [95% CI] 1.0-11.5], 12.6 (95% CI 2.3-274), and 48.8 (95% CI 9.3-904), respectively., Conclusion: Our findings suggest that structural progression does exist in early SpA, but it is quite small and observed in a small number of patients, and that environmental (smoking status), genetic (HLA-B27 positivity), and inflammation (inflammation of the SI joints on MRI) markers might be independent predisposing factors for progression., (© 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.)

Purpose: Eastern Cooperative Oncology Group Performance Status (ECOG-PS) is currently an important parameter in the choice of treatment strategy for metastatic pancreatic adenocarcinoma (mPA) patients. However, previous research has shown that patients' self-reported health-related quality of life (HRQOL) scales provided additional prognostic information in homogeneous groups of patients with respect to ECOG-PS. The aim of this study was to identify HRQOL scales with independent prognostic value in mPA and to propose prognostic groups for these patients., Methods: We analysed data from 98 chemotherapy-naive patients with histologically proven mPA recruited from 2007 to 2011 in the FIRGEM phase II study which aimed to compare the effectiveness of two chemotherapy regimen. HRQOL data were assessed with the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. A random survival forest methodology was used to impute missing data and to identify major prognostic factors for overall survival., Results: Baseline HRQOL assessment was completed by 60 % of patients (59/98). Twelve prognostic variables were identified. The three most important prognostic variables were fatigue, appetite loss, and role functioning, followed by three laboratory variables. The model's discriminative power assessed by Harrell's C statistic was 0.65. Fatigue score explained almost all the survival variability., Conclusion: HRQOL scores have prognostic value for mPA patients with good ECOG-PS. Moreover, the patient's fatigue, appetite loss, and self-perception of daily activities were more reliable prognostic indicators than clinical and laboratory variables. These HRQOL scores, especially the fatigue symptom, should be urgently included for prognostic assessment of mPA patients (with good ECOG-PS).

Background: The treatment of fracture sequelae of the proximal part of the humerus in combination with posttraumatic arthritis is challenging. The reported results of treatment with anatomic shoulder arthroplasty are disappointing. The aim of this multicenter study was to analyze the clinical and radiographic results of reverse shoulder arthroplasty for treatment of posttraumatic sequelae of the proximal part of the humerus with malunion of the tuberosities., Methods: This was a retrospective, multicenter study of 42 patients (42 shoulders) with the diagnosis of posttraumatic sequelae of the proximal part of the humerus with malunions of the tuberosities who were treated with reverse shoulder arthroplasty between 2000 and 2010. The mean age at the time of arthroplasty was 68 years (range, 27 to 83 years; median, 70 years). The dominant side was treated in 24 cases. The mean clinical and radiographic follow-up was 4 years (range, 2 to 13 years; median, 3.5 years). The Constant score including subgroups, shoulder flexion, rotation motion, and radiographs of the affected shoulders were analyzed before the surgical procedure and at the time of the latest follow-up. Patients categorized their postoperative results as very good, good, satisfactory, or unsatisfactory., Results: The mean Constant score increased from 19.7 points (range, 0 to 52 points) preoperatively to 54.9 points (range, 21 to 83 points) postoperatively (p < 0.0001). All of the subgroups of the Constant score also increased, as did active shoulder flexion and external rotation (all p < 0.0001). In one case, loosening of the humeral and glenoid components occurred. Scapular notching was present in 22 shoulders (52%) and was grade 1 in 12 cases, grade 2 in 4 cases, grade 3 in 2 cases, and grade 4 in 4 cases. Complications occurred in 4 patients (9.5%). Eighteen patients (43%) rated their result as very good, 19 (45%) rated their result as good, 4 (10%) rated their result as satisfactory, and one (2%) rated the result as unsatisfactory., Conclusions: Reverse shoulder arthroplasty is a viable treatment option for type-4 proximal humeral fracture sequelae that cannot otherwise be treated with anatomic shoulder replacement., Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence., (Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.)

Background: Maintenance strategies beyond response or tumor stabilization with first-line chemotherapy in metastatic breast cancer (MBC) have not been extensively studied. Endocrine therapy combined with continued bevacizumab may be a helpful option for estrogen receptor (ER)-positive MBC., Patients and Methods: In this prospective, open-label, phase III study, patients with histologically confirmed ER-positive, HER2-negative MBC and non-progressive disease after 16-24 weeks of taxane plus bevacizumab (T + BEV) were randomized to continuation of T + BEV or maintenance bevacizumab plus exemestane (E + BEV). The primary end point was progression-free survival (PFS) from randomization. To have 80% power to detect an improvement in the 6-month PFS rate (PFS6m) from 50% to 65%, 186 assessable patients were needed for a total of 141 PFS events. An interim analysis was planned after 40% of the required events., Results: The interim analysis with 98 patients showed that the probability of reaching a statistically significant improvement in PFS by the end of the study was only 7%. This led the Independent Data and Monitoring Committee to recommend termination of patient enrollment. After a median of 21-month follow-up of all randomized patients (117 in total), PFS6m from randomization was 67.2% [95% confidence interval (CI) 53.6-77.7] with T + BEV and 55.2% (95% CI 41.5-66.9) with E + BEV [hazard ratio (HR): 1.0, 95% CI 0.7-1.5, P = 0.998]. Median PFS from BEV initiation was 12.5 and 12.3 months in the T + BEV and E + BEV arms, respectively. In the T + BEV arm, taxane was prematurely stopped for the majority of patients (94.9%), mainly due to toxicity (49.2%). Updated data after 35 months' median follow-up showed death rates of 44% and 55% in T + BEV and E + BEV arms, respectively., Conclusion: In this trial, maintenance therapy with E + BEV in ER-positive, HER2-negative MBC patients with no evidence of progression after first-line T + BEV did not achieve longer PFS compared with continuation of T + BEV., Clinicaltrialsgov: NCT01303679., (© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Interest and knowledge on the anatomy, function, and biomechanical properties of the anterolateral ligament has led to the recognition of the importance of this structure in rotational control of the knee. This article describes a technique that allows for a combined anterior cruciate ligament (ACL) and anterolateral reconstruction, using an Iliotibial band (ITB) autograft. The graft is detached from the vastus lateralis from proximal to distal, at the center portion from ITB, preserving its distal insertion on the Gerdy tubercle. Its width is 1 cm for the distal part, used for the anterolateral ligament reconstruction, and 3 cm for the proximal part. An outside-in femoral tunnel is drilled respecting both the preferred favorable isometric femoral insertion site and the femoral ACL footprint. An ACL reconstruction combined with a lateral tenodesis with a continuous ITB graft respects the anatomical and isometric rules providing superior internal rotational control of the knee in comparison with a stand-alone ACL reconstruction.

Recent evidence on the anatomy, function, and biomechanical properties of the anterolateral ligament has led to the recognition of the importance of this structure in the rotational control of the knee. This article describes a technique that allows for minimally invasive anterolateral ligament reconstruction as a complement to most techniques of anterior cruciate ligament reconstruction. A gracilis tendon autograft is harvested and prepared in a double-strand, inverted V-shaped graft. The graft is percutaneously placed through a femoral stab incision, and each strand is then passed deep to the iliotibial band, emerging through each tibial stab incision. After the femoral-end loop graft is fixed, the tibial fixation of each strand is performed in full extension for optimal isometry.

Background: The β-angle, formed by the intersection of a line on the floor of the supraspinatus fossa and glenoid fossa line, has been described as a reliable measurement tool in the clinical setting to analyze glenoid inclination on the anteroposterior (AP) view of the shoulder. The purpose of this study was to compare the accuracy of the β-angle measurement using different imaging modalities with a validated 3-dimensional (3D) software tool., Materials and Methods: The β-angle was measured on AP radiographs, unformatted 2-dimensional (2D) computed tomography (CT) scan, and reformatted 2D CT scan in the scapular plane for 51 shoulders of 49 patients undergoing primary total shoulder arthroplasty. Comparison to the glenoid inclination angle calculated by the 3D software was performed., Results: The β-angle measured on reformatted CT scan was found to be the most accurate measurement method, with a mean difference of 1° (standard deviation [SD], 0.5°) with respect to 3D measurement. On AP radiographs, the β-angle was not as accurate, with a mean difference of 3° (SD, 0.7°; P < .006). The β-angle on unformatted 2D CT scan was not a reliable method to measure glenoid inclination, with a mean difference of 10° (SD, 0.9°; P < .0001)., Conclusion: The β-angle measured with 2D CT scan formatted in the scapular plane was the most accurate method for measuring glenoid inclination. The β-angle on the AP radiograph is less accurate and reliable. Measurement of the β-angle on an unformatted 2D CT scan is not an acceptable method to determine glenoid inclination., (Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Increased critical shoulder angles consist of both the acromial cover and glenoid inclination and have been found in patients with rotator cuff pathology. The purpose of this study was to determine the correlation of the critical shoulder angle and glenoid inclination and to determine the difference in glenoid inclination between patients with osteoarthritis and massive rotator cuff tears., Methods: The critical shoulder angle and glenoid inclination were measured on anteroposterior radiographs, and glenoid inclination was also measured on a validated 3-dimensional computer software program of 50 shoulders undergoing primary total shoulder arthroplasty. Twenty-five shoulders had osteoarthritis and A1 glenoids, as defined by the Walch classification, and were undergoing anatomic shoulder arthroplasty. The other 25 shoulders had massive rotator cuff tears and E0 glenoids, as defined by the Favard classification. The 2 groups were compared., Results: Critical shoulder angle and glenoid inclination were significantly correlated (R(2) = 0.7426, P < .001). Shoulders with massive rotator cuff tears (E0) demonstrated increased glenoid inclination measurements than shoulders with osteoarthritis (A1). As measured by the 3-dimensional software, the massive rotator cuff group had a glenoid inclination of 13.6° ± 4.3° and the osteoarthritis group had a glenoid inclination of 4.7° ± 5.6°. When measured by anteroposterior radiographs, the average glenoid inclination was 13.6° ± 4.6° in the massive rotator cuff group and was 7.6° ± 5.01° in the osteoarthritic group ., Conclusion: Glenoid inclination is linearly correlated with the critical shoulder angle and is significantly increased in patients with massive rotator cuff tears., (Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: The combination of an anti-VEGF or an anti-EGFR-targeted monoclonal antibody with chemotherapy has shown clinical activity in patients with metastatic colorectal cancer. However, combining both anti-VEGF and anti-EGFR antibodies with chemotherapy in first-line treatment resulted in adverse outcomes. We assessed whether the combination of erlotinib, an EGFR tyrosine kinase inhibitor, with bevacizumab could increase the efficacy of maintenance therapy in patients with unresectable metastatic colorectal cancer., Methods: This randomised, open-label, phase 3 study was undertaken in 49 centres in France, Austria, and Canada. Eligible patients were aged 18-80 years with histologically confirmed, unresectable metastatic colorectal cancer, WHO performance status 0-2, had received no previous therapy for metastatic disease, and had adequate organ function. Patients without disease progression after bevacizumab-based induction therapy were randomly assigned (1:1) by a minimisation technique to bevacizumab (7·5 mg/kg every 3 weeks) or bevacizumab plus erlotinib (150 mg once daily) as maintenance therapy until progression. All patients were stratified by centre, baseline performance status, age, and number of metastatic sites. The primary endpoint was progression-free survival on maintenance therapy analysed by intention to treat. We report the final analysis. This trial is registered with ClinicalTrials.gov, number NCT00265824., Findings: Between Jan 1, 2007, and Oct 13, 2011, 700 eligible patients were enrolled; following induction treatment, patients without disease progression were randomly assigned to bevacizumab (n=228) or bevacizumab plus erlotinib (n=224). At the final analysis, median follow-up was 51·0 months (IQR 36·0-60·0) in the bevacizumab group and 48·3 months (31·5-61·0) in the bevacizumab plus erlotinib group. In the primary analysis (after 231 progression-free survival events), median progression-free survival from randomisation was 5·1 months (95% CI 4·1-5·9) in the bevacizumab plus erlotinib group compared with 6·0 months (4·6-7·9) in the bevacizumab group (stratified hazard ratio [HR] 0·79 [95% CI 0·60-1·06]; p=0·11; unstratified HR 0·76 [0·59-0·99]; p=0·043). In the final analysis, median progression-free survival from randomisation was 5·4 months (95% CI 4·3-6·2) in the bevacizumab plus erlotinib group compared with 4·9 months (4·1-5·7) in the bevacizumab group (stratified HR 0·81 [95% CI 0·66-1·01], p=0·059; unstratified HR 0·78 [0·68-0·96], p=0·019). At the final analysis, median overall survival from maintenance was 24·9 months (95% CI 21·4-28·9) in the bevacizumab plus erlotinib group and 22·1 months (19·6-26·7) in the bevacizumab group (stratified HR 0·79 [95% CI 0·63-0·99], p=0·036; unstratified HR 0·79 [0·64-0·98], p=0·035). The most frequent grade 3-4 adverse events were skin rash (47 [21%] of 220 patients in the bevacizumab plus erlotinib group vs none of 224 patients in the bevacizumab alone group), diarrhoea (21 [10%] vs two [<1%]), and asthenia (12 [5%] vs two [<1%])., Interpretation: Maintenance bevacizumab plus erlotinib might be a new non-chemotherapy-based maintenance option for the first-line treatment of patients with unresectable metastatic colorectal cancer after bevacizumab-based induction therapy., Funding: GERCOR and F Hoffmann-La Roche., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Long lasting elevation is a key factor during endoscopic submucosal dissection (ESD) and can be obtained by water jet injection of saline solution or by viscous macromolecular solutions. In a previous animal study, we assessed the Nestis Enki II system to combine jet injection and viscous solutions. In the present work, we used this combination in humans in different sites of the digestive tract., Methods: We retrospectively report all of the consecutive ESD procedures performed with jet injection of viscous solutions in four centers. Information was collected about the lesion, the procedure, the histological result, and the outcomes for the patient., Results: In total, 45 resections were completed by six operators: five experts and one beginner with only one previous experience in human ESD. Lesions were located in the esophagus (10), the stomach (11), the duodenum (1), the colon (1) and the rectum (22). Average maximal lesion diameter was 4.8 cm (SD 2.4, range 2 - 11 cm), average lesion surface area was 19.8 cm(2) (SD 17.7, range 2.2 - 72 cm(2)), and average duration of procedure was 79.9 min (SD 50.3 min, range 19 - 225 min). ESD could be conducted while the endoscope was retroflexed at its maximum in 26 cases. Four adverse events were observed: two diminutive perforations and two delayed bleeding occurrences treated conservatively. The R0 resection rate was 91.1 %. The catheter was obstructed in six occurrences of bleeding., Conclusion: Endoscopic submucosal dissection using high pressure injection of viscous macromolecular solutions is safe and effective in different parts of the digestive tract. It does not impede working with the endoscope in the maximal retroflexed position.

Background and Aims: The heterogeneous nature of breast cancer can make decisions on adjuvant chemotherapy following surgical resection challenging. Oncotype DX is a validated gene expression profiling test that predicts the likelihood of adjuvant chemotherapy benefit in early-stage breast cancer. The aim of this study is to determine the costs of chemotherapy in private hospitals in France, and evaluate the cost-effectiveness of Oncotype DX from national insurance and societal perspectives., Methods: A multicenter study was conducted in seven French private hospitals, capturing retrospective data from 106 patient files. Cost estimates were used in conjunction with a published Markov model to assess the cost-effectiveness of using Oncotype DX to inform chemotherapy decision making versus standard care. Sensitivity analyses were performed., Results: The cost of adjuvant chemotherapy in private hospitals was estimated at EUR 8,218 per patient from a national insurance perspective and EUR 10,305 from a societal perspective. Cost-effectiveness analysis indicated that introducing Oncotype DX improved life expectancy (+0.18 years) and quality-adjusted life expectancy (+0.17 QALYs) versus standard care. Oncotype DX was found cost-effective from a national insurance perspective (EUR 2,134 per QALY gained) and cost saving from a societal perspective versus standard care. Inclusion of lost productivity costs in the modeling analysis meant that costs for eligible patients undergoing Oncotype DX testing were on average EUR 602 lower than costs for those receiving standard care., Conclusions: As Oncotype DX was found both cost and life-saving from a societal perspective, the test was considered to be dominant to standard care. However, the delay in coverage has the potential to erode the quality of the French healthcare system, thus depriving patients of technologies that could improve clinical outcomes and allow healthcare professionals to better allocate hospital resources to improve the standard of care for all patients.

Hypothesis and Background: The Latarjet procedure is a reliable treatment of recurrent anterior shoulder instability. The coracoid process is usually fixed with metallic screws; however, these can lead to irritation and the necessity for hardware removal and also can produce artifacts on imaging studies. The use of resorbable screws could avoid these complications. The purpose of this study was to assess the clinical results of the Latarjet procedure performed with bioabsorbable screws in addition to healing of the graft and resorption of the screws., Methods: In 2009, we performed a prospective study (case series,, Level of Evidence: IV) of 11 patients (12 shoulders) who underwent a Latarjet procedure fixed with resorbable screws. Each patient was observed clinically and had a computed tomography scan at 3 months and 2 years of follow-up., Results: Every graft healed at 3-month follow-up. At 2-year follow-up, 4 patients had at least one instability episode, and one underwent a revision surgery. Three of these 4 patients were unhappy or disappointed. The Walch-Duplay score was excellent or good for 7 shoulders and medium or poor for 5. Screw resorption appeared complete in every case. No drill hole enlargement was observed. Every drill hole was partially filled with bone. Of 12 shoulders, 8 (66.67%) were associated with a severe osteolysis and an almost complete disappearance of the graft., Conclusion: Coracoid graft osteolysis, previously reported after the Latarjet procedure, appears to be exacerbated with a risk of complete disappearance of the graft when the procedure is performed with the bioabsorbable screws used in this study., (Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Glenoid component positioning is a key factor for success in total shoulder arthroplasty. Three-dimensional (3D) measurements of glenoid retroversion, inclination, and humeral head subluxation are helpful tools for preoperative planning. The purpose of this study was to assess the reliability and precision of a novel surgical method for placing the glenoid component with use of patient-specific templates created by preoperative surgical planning and 3D modeling., Methods: A preoperative computed tomography examination of cadaveric scapulae (N = 18) was performed. The glenoid implants were virtually placed, and patient-specific guides were created to direct the guide pin into the desired orientation and position in the glenoid. The 3D orientation and position of the guide pin were evaluated by performing a postoperative computed tomography scan for each scapula. The differences between the preoperative planning and the achieved result were analyzed., Results: The mean error in 3D orientation of the guide pin was 2.39°, the mean entry point position error was 1.05 mm, and the mean inclination angle error was 1.42°. The average error in the version angle was 1.64°. There were no technical difficulties or complications related to use of patient-specific guides for guide pin placement. Quantitative analysis of guide pin positioning demonstrated a good correlation between preoperative planning and the achieved position of the guide pin., Conclusion: This study demonstrates the reliability and precision of preoperative planning software and patient-specific guides for glenoid component placement in total shoulder arthroplasty., (Copyright © 2015. Published by Elsevier Inc.)

Background: The aim of this study was to investigate the histological features of the remaining fibers bridging the femur and tibia in partial ACL tears., Methods: Twenty-six ACL remnants were harvested from patients who had arthroscopic criteria concordant with a partial tear. Histological analysis includes cellularity, blood vessel density evaluation and characterization of the femoral bony insertion morphology. Immunohistochemical studies were carried out to determine cells positive for α-smooth actin and for mechanoreceptor detection., Results: In these samples, a normal femoral insertion of the remnant was present in 22.7% of the cases. In 54% of the samples, substantial areas of hypercellularity were observed. Myofibroblasts were the predominant cell type and numerous cells positive for α-smooth actin were detected at immunostaining. Blood vessel density was increased in hypercellularity areas and in the synovial sheet. Free nerve endings and few Golgi or Ruffini corpuscles were detected in 41% of the specimens. The cellularity was correlated to the time between injury to surgery (p=0.001)., Conclusion: Competent histological structures including a well-vascularized synovial sheet, numerous fibroblasts and myofibroblasts and mechanoreceptors were found in ACL remnants. These histological findings bring additional knowledge towards the preservation of the ACL remnant in partial tears when ACL reconstruction or augmentation is considered., Clinical Relevance: Descriptive laboratory study., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: Fluorouracil and irinotecan-based, and gemcitabine-based regimens, are the standard of care in the first-line treatment of patients with metastatic pancreatic cancer. New approaches are needed to improve survival and quality of life. Whether a sequential approach alternating irinotecan, fluorouracil and gemcitabine may be effective and tolerable in patients with metastatic pancreatic cancer is unknown., Methods: In this randomised, multicentre, open-label, phase 2 trial, patients with metastatic pancreatic adenocarcinoma, World Health Organisation (WHO) performance status 0-1, and bilirubin levels <1.5 upper limit of normal values (ULN) were randomised 1:1 to receive as first-line treatment either FOLFIRI.3 (irinotecan, leucovorin and fluorouracil) alternating with fixed-dose rate gemcitabine as 2-month periods (FIRGEM, arm A), or fixed-dose rate gemcitabine alone (arm B). Treatment was continued until disease progression or limiting toxicity. The primary end-point was the crude progression-free survival (PFS) rate at 6 months. The study is registered with EudraCT (N° 2006-005703-34)., Results: Between October 2007 and March 2011, 98 patients were enroled. The observed 6-month PFS rate was 43.5% (95% confidence interval (CI), [28.6-58.4%]) in arm A reaching the Fleming decision rules criteria to reject H0 and 26.1% (95% CI [12.9-39.3%]) in arm B. Objective response rates were 37% (23-51%) in arm A and 10% (1-19%) in arm B. Median PFS (5.0 versus 3.4 months, hazard ratio (HR)=0.59 [0.38-0.90]) and overall survival (11.0 versus 8.2 months, HR=0.71 [0.46-1.10]) were higher in arm A compared to arm B. The most frequent grade 3-4 toxicities were neutropenia (49%/24%; febrile neutropenia, 4%/0% in arms A/B), diarrhoea (arm A, 12% and arm B, 0%), and nausea/vomiting (8%/4%). No toxic deaths occurred., Conclusion: The FIRGEM strategy appears to be effective and feasible in patients with metastatic pancreatic cancer., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Arthroscopy is becoming an essential tool for the treatment of chronic lateral ankle instability. It allows the surgeon to determine which ligaments are injured and choose the most appropriate surgical repair technique, and also to assess and treat any associated injuries. Several arthroscopic techniques for lateral ankle ligament repair have recently been developed. As a consequence, it may be possible to carry out complete lateral ligament reconstruction with an all-arthroscopic procedure. Such an arthroscopic lateral ankle ligament reconstruction technique is described in this article., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Over the last decade, the development of stabilised microbubble contrast agents and improvements in available ultrasonic equipment, such as harmonic imaging, have enabled us to display microbubble enhancements on a greyscale with optimal contrast and spatial resolution. Recent technological advances made contrast harmonic technology available for endoscopic ultrasound (EUS) for the first time in 2008. Thus, the evaluation of microcirculation is now feasible with EUS, prompting the evolution of contrast-enhanced EUS from vascular imaging to images of the perfused tissue. Although the relevant experience is still preliminary, several reports have highlighted contrast-enhanced harmonic EUS (CH-EUS) as a promising noninvasive method to visualise and characterise lesions and to differentiate benign from malignant focal lesions. Even if histology remains the gold standard, the combination of CH-EUS and EUS fine needle aspiration (EUS-FNA) can not only render EUS more accurate but may also assist physicians in making decisions when EUS-FNA is inconclusive, increasing the yield of EUS-FNA by guiding the puncture with simultaneous imaging of the vascularity. The development of CH-EUS has also opened up exciting possibilities in other research areas, including monitoring responses to anticancer chemotherapy or to ethanol-induced pancreatic tissue ablation, anticancer therapies based on ultrasound-triggered drug and gene delivery, and therapeutic adjuvants by contrast ultrasound-induced apoptosis. Contrast harmonic imaging is gaining popularity because of its efficacy, simplicity and non-invasive nature, and many expectations are currently resting on this technique. If its potential is confirmed in the near future, contrast harmonic imaging will become a standard practice in EUS.

Lateral ankle sprains are common; if conservative treatment fails and chronic instability develops, stabilization surgery is indicated. Numerous surgical procedures have been described, but those that most closely reproduce normal ankle lateral ligament anatomy and kinematics have been shown to have the best outcomes. Arthroscopy is a common adjunct to open ligament surgery, but it is traditionally only used to improve the diagnosis and the management of any associated intra-articular lesions. The stabilization itself is performed open because standard anterior ankle arthroscopy provides only partial visualization of the anterior talofibular ligament from above and the calcaneofibular ligament attachments cannot be seen at all. However, lateral ankle endoscopy can provide a view of this area that is superior to open surgery. We have developed a technique of ankle endoscopy that enables anatomic positioning of the repair or fixation of the graft. In this article we describe a safe and reproducible arthroscopic anatomic reconstruction of the lateral ligaments of the ankle using a gracilis autograft. The aim of this procedure is to obtain a more physiological reconstruction while maintaining all the advantages of an arthroscopic approach.

Background: Physicians should consider an increased posterior tibial slope (PTS) as a risk factor for graft failure when proposing anterior cruciate ligament (ACL) re-revision., Purpose: To describe the surgical technique of combined ACL revision and proximal tibial anterior closing wedge osteotomy and to evaluate its clinical outcome in cases of recurrent graft failure with associated increased tibial slope., Study Design: Case series; Level of evidence, 4., Methods: Between 2008 and 2010, 5 combined ACL re-revisions with proximal tibial anterior closing wedge osteotomy were retrospectively evaluated after a mean 31.6 months' follow-up (range, 23-45 months). All patients reported subjective knee instability preoperatively and demonstrated increased laxity on physical examination. Intrinsic risk factors for graft failure (excessive tibial slope) were identified in all cases. Preoperative and postoperative functional assessments included the International Knee Documentation Committee (IKDC) score along with the Lysholm score and Tegner activity scale., Results: The mean Lysholm score was 46.2 preoperatively (range, 26-69) and 87.8 (range, 60-100) postoperatively. The mean IKDC subjective score was 39.5 (range, 21.8-64.4) before surgery and 79.1 (range, 48.3-98.9) at the last follow-up. The mean Tegner activity score was 7.4 (range, 5-9) before the latest ACL injury and 7.2 (range, 5-9) at the last follow-up. The mean PTS was 13.6° (range, 13°-14°) preoperatively and 9.2° (range, 8°-10°) postoperatively (P = .0005). The mean differential anterior laxity was 10.4 mm (range, 8-14 mm), and this significantly decreased to 2.8 mm (range, 2-4 mm) at the last follow-up. Using the Kellgren-Lawrence classification to evaluate the presence of arthritis, 1 patient was grade 1, 3 patients were grade 2, and 1 patient was grade 3., Conclusion: Combined ACL re-revision with proximal tibial anterior closing wedge osteotomy restores knee stability and function with satisfactory clinical outcomes in patients who experience recurrent ACL ruptures with an associated increased PTS., (© 2014 The Author(s).)

Intense interest has focused on the recent description of the anterolateral ligament of the knee. Advancing knowledge of its anatomy and function is leading to a realization of its importance in the rotatory control of the tibia in anterior cruciate ligament injuries. Reconstruction of this structure will increasingly become an important goal during anterior cruciate ligament reconstruction. However, preoperative assessment of this ligament is difficult. Clinical assessment of rotatory laxity has poor reproducibility, and it is difficult to define using current imaging techniques. This article is the first to describe a safe and reproducible arthroscopic technique to allow identification and examination of the anterolateral ligament of the knee. With the knee at 90° of flexion, the arthroscope is introduced through the anterolateral portal to allow clear visualization of the lateral gutter. Under direct vision, an accessory portal is made over the inferior limit of the lateral gutter. A shaver is then introduced through this portal and used to debride this synovial recess and define the anterolateral ligament. This allows the surgeon to examine the integrity of the anterolateral ligament, in particular its femoral insertion. If required, this additional information can facilitate the performance of a more accurate and effective extra-articular reconstruction.

The anterior cruciate ligament TightRope RT (Arthrex, Naples, FL) is a graft suspension device for cruciate ligament reconstruction. It is an adjustable-length graft loop cortical fixation device designed to eliminate the requirement for loop length calculation and to facilitate complete graft fill of short femoral sockets that are common with anatomic anterior cruciate ligament placement. The adjustable loop length means "one size fits all," thus removing the need for multiple implant sizes and allowing graft tensioning even after fixation. However, the device has been associated with the same complications that have been described with EndoButton (Smith & Nephew Endoscopy, Andover, MA) fixation. The button of the TightRope RT may remain in the femoral tunnel rather than flipping outside of the tunnel to rest on the lateral femoral cortex, or it may become jammed inside the femoral canal. Conversely, the button may be pulled too far off the femoral cortex into the overlying soft tissue and flip in the substance of the vastus lateralis. We describe a new and simple arthroscopic technique to directly visualize the deployment and seating of the TightRope button on the lateral cortex of the femur to avoid all the aforementioned complications.

Background and Study Aims: Endoscopic papillectomy of early tumors of the ampulla of Vater is an alternative to surgery. This large prospective multicenter study was aimed at evaluating the long-term results of endoscopic papillectomy., Patients and Methods: Between September 2003 and January 2006, 10 centers included all patients referred for endoscopic papillectomy and meeting the inclusion criteria: biopsies showing at least adenoma, a uT1N0 lesion without intraductal involvement at endoscopic ultrasound (EUS), and no previous treatment. A standardized endoscopic papillectomy was done, with endoscopic monitoring with biopsies 4 - 8 weeks later where complications were recorded and complementary resection performed when necessary. Follow-up with duodenoscopy, biopsies, and EUS was done at 6, 12, 18, 24 and 36 months. Therapeutic success was defined as complete resection (no residual tumor found at early monitoring) without duodenal submucosal invasion in the resection specimen in the case of adenocarcinoma and without relapse during follow-up., Results: 93 patients were enrolled. Mortality was 0.9 % and morbidity 35 %, including pancreatitis in 20 %, bleeding 10 %, biliary complications 7 %, perforation 3.6 %, and papillary stenosis in 1.8 %. Adenoma was not confirmed in the resection specimen in 14 patients who were therefore excluded. Initial treatment was insufficient in 9 cases (8 carcinoma with submucosal invasion; 1 persistence of adenoma). During follow-up, 5 patients had tumor recurrence and 7 died from unrelated diseases without recurrence. Finally, 81.0 % of patients were cured (95 % confidence interval 72.3 % - 89.7 %)., Conclusion: Endoscopic papillectomy of selected ampullary tumors is curative in 81.0 % of cases. It must be considered to be the first-line treatment for early tumors of the ampulla of Vater without intraductal invasion., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Augmentation consisting of a selective reconstruction of the ruptured bundle while preserving the remnant bundle has been proposed as a treatment option for partial anterior cruciate ligament (ACL) tears. Good clinical outcomes after selective anteromedial (AM) bundle augmentation have been reported, whereas little is known about selective reconstruction of the posterolateral (PL) bundle with preservation of the AM bundle remnant., Purpose: The purpose of this study was to evaluate the clinical outcomes and the magnetic resonance imaging (MRI) characteristics of selective PL bundle reconstruction with a median follow-up of 24 months., Study Design: Case series; Level of evidence, 4., Methods: In a consecutive series of 741 ACL reconstructions, 44 patients underwent a selective PL bundle reconstruction with preservation of the AM remnant. Four patients with contralateral knee ligament surgery and 1 patient who sustained a traumatic rupture of his graft were excluded, leaving 39 patients for final evaluation. Clinical evaluation of knee function and laxity were recorded preoperatively and at a mean 24.2-month follow-up. Magnetic resonance imaging was performed on 35 patients at a mean 25.9-month follow-up for evaluation of graft and remnant bundle continuity, tunnel enlargement, and graft remodeling status by measuring the signal intensity of the graft (contrast/noise quotient [CNQ])., Results: Tegner and Lysholm knee scores were significantly improved after surgery. The subjective International Knee Documentation Committee (IKDC) score was 43.5 ± 16.6 preoperatively and 89.9 ± 6.6 at the final follow-up (P < .01). The objective IKDC score was "B" for 17 patients, "C" for 21 patients, and "D" for 1 patient preoperatively, while it was "A" for 34 patients and "B" for 5 patients postoperatively (P < .01). The mean side-to-side anteroposterior laxity was 5 mm (range, 4-10 mm) preoperatively and 1.5 mm (range, -1 to 4 mm) at final follow-up (P < .01). On MRI, the graft was visible and continuous in all cases. No cyclops lesions were noted. The average CNQ for the PL graft and the AM remnant bundle was 3.2 ± 1 and 2.9 ± 1.2, respectively. Minimum bone tunnel enlargement was found., Conclusion: Selective PL bundle reconstruction restores knee stability and function. At final follow-up, MRI showed continuity of the PL graft without signs of dramatic tunnel enlargement or cyclops syndrome.

Background: The purpose of this study was to evaluate the combination of panitumumab and irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy (oxaliplatin, fluoropyrimidines-irinotecan and bevacizumab)., Patients and Methods: KRAS status was first determined locally but subsequent validation of KRAS status and additional screenings (rare KRAS, NRAS, BRAF mutations and EGFR copy number) were centrally assessed. Patients received panitumumab (6 mg/kg) and irinotecan (180 mg/m²) every 2 weeks., Results: Sixty-five eligible patients were analyzed. The objective response rate (ORR) was 29.2% [95% confidence interval (95% CI) 18.2-40.3]. Median progression-free and overall survivals were 5.5 and 9.7 months, respectively. Most frequent grade 3/4 toxic effects were skin 32.3%, diarrhea 15.4% and neutropenia 12.3%. Tissue samples were available for 60 patients. For the confirmed KRAS wild-type population codon 12 or 13 mutation (n = 54), ORR was 35.2% (95% CI 22.4.1-47.9). Thirteen patients had a NRAS, a BRAF or a rare KRAS mutation, and no tumor response was observed in this subgroup when compared with 46.3% (95% CI 31.1-61.6) ORR in the subgroup of 41 patients with no identified mutation., Conclusion: Panitumumab and irinotecan is an active third-line regimen in a well-defined population based on biomarkers. ClinicalTrials.gov Identifier NCT00655499.

Background and Study Aims: Distinguishing pancreatic adenocarcinoma from other pancreatic masses remains challenging with current imaging techniques. This prospective study aimed to evaluate the accuracy of a new procedure, imaging the microcirculation pattern of the pancreas by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) with a new Olympus prototype echo endoscope., Patients and Methods: 35 patients presenting with solid pancreatic lesions were prospectively enrolled. All patients had conventional B mode and power Doppler EUS. After an intravenous bolus injection of 2.4 ml of a second-generation ultrasound contrast agent (SonoVue) CEH-EUS was then performed with a new Olympus prototype echo endoscope (xGF-UCT 180). The microvascular pattern was compared with the final diagnosis based on the pathological examination of specimens from surgery or EUS-guided fine-needle aspiration (EUS-FNA) or on follow-up for at least 12 months., Results: The final diagnoses were: 18 adenocarcinomas, 9 neuroendocrine tumors, 7 chronic pancreatitis, and 1 stromal tumor. Power Doppler failed to display microcirculation, whereas harmonic imaging demonstrated it in all cases. Out of 18 lesions with a hypointense signal on CEH-EUS, 16 were adenocarcinomas. The sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy of hypointensity for diagnosing pancreatic adenocarcinoma were 89 %, 88 %, 88 %, 89 %, and 88.5 %, compared with corresponding values of 72 %, 100 %, 77 %, 100 %, and 86 % for EUS-FNA. Of five adenocarcinomas with false-negative results at EUS-FNA, four had a hypointense echo signal at CEH-EUS., Conclusions: CEH-EUS with the new Olympus prototype device successfully visualizes the microvascular pattern in pancreatic solid lesions, and may be useful for distinguishing adenocarcinomas from other pancreatic masses.