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Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information. A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded. Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ =.245 [blinded] and κ =.321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ =.059-.400 vs κ =.031-.452). This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment. [ABSTRACT FROM AUTHOR]

Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P =.131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P =.999), median ERCP completion time (25.0 vs 28.5 minutes, P =.130), mean cannulation attempts (2.8 vs 2.8, P =.954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P =.840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P <.001). Serious adverse events were reported in 13 patients (6.5%). In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.) [Display omitted] [ABSTRACT FROM AUTHOR]

Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P =.008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P <.001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ±.6 (P <.001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P =.568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov , Number: NCT01543256.) [Display omitted] For benign biliary stricture secondary to chronic pancreatitis, 12-month endotherapy using a single fully covered self-expandable metal stent has similar efficacy and safety and requires fewer procedural interventions than multiple plastic stents. [ABSTRACT FROM AUTHOR]

Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT. We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs). In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10). By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.) [ABSTRACT FROM AUTHOR]

Rapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome. The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed. FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online. This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions. [ABSTRACT FROM AUTHOR]

In high-risk individuals (HRIs), we aimed to assess the cumulative incidence of intraductal papillary mucinous neoplasms (IPMNs) and compare IPMN growth, neoplastic progression rate, and the value of growth as predictor for neoplastic progression to these in sporadic IPMNs. We performed annual surveillance of Dutch HRIs, involving carriers of germline pathogenic variants (PVs) and PV-negative familial pancreatic cancer kindreds. HRIs with IPMNs were compared with Italian individuals without familial risk under surveillance for sporadic IPMNs. A total of 457 HRIs were followed for 48 (range 2–172) months; the estimated cumulative IPMN incidence was 46% (95% confidence interval, 28%–64%). In comparison with 442 control individuals, IPMNs in HRIs were more likely to grow ≥2.5 mm/y (31% vs 7%; P <.001) and develop worrisome features (32% vs 19%; P =.010). PV carriers with IPMNs more often displayed neoplastic progression (n = 3 [11%] vs n = 6 [1%]; P =.011), while familial pancreatic cancer kindreds did not (n = 0 [0%]; P = 1.000). The malignancy risk in a PV carrier with an IPMN was 23% for growth rates ≥2.5 mm/y (n = 13), 30% for ≥5 mm/y (n = 10), and 60% for ≥10 mm/y (n = 5). The cumulative incidence of IPMNs in HRIs is higher than previously reported in the general population. Compared with sporadic IPMNs, they have an increased growth rate. PV carriers with IPMNs are suggested to be at a higher malignancy risk. Intensive follow-up should be considered for PV carriers with an IPMN growing ≥2.5 mm/y, and surgical resection for those growing ≥5 mm/y. [ABSTRACT FROM AUTHOR]

Background and Aims In chronic pancreatitis (CP), fibrotic pancreatic duct (PD) strictures pose a therapeutic challenge, because endoscopic dilatation requires multiple procedures with suboptimal results. Biodegradable self-expandable stents (BD-SESs) may serve as an alternative in this setting. Methods Patients with CP were eligible for this proof-of-principle study if at least 6 months of endoscopic dilatation with plastic stents had failed to resolve their PD stricture. The non-covered BD-SESs were expected to degrade within 3 to 6 months. Patients were followed at 3-monthly intervals for 1 year. Placement success and safety were the primary outcome parameters. Stricture resolution was assessed by ERCP after 6 months. Results BD-SESs were successfully placed in all 19 patients without adverse events. In 2 cases, stent occlusion with sludge and stones was treated by a balloon swipe. One stent disintegrated during this procedure, after which placement of the plastic stent was resumed. A hyperplastic response was observed in 2 patients but did not result in functional obstruction. Stricture resolution was accomplished in 11 patients (technical success rate 58%). Six patients required further treatment of their PD stricture, 4 endoscopically and 2 surgically. Three additional patients underwent surgery for other reasons: 2 Whipple procedures for CP-related adverse events and one tail resection for an intraductal papillary mucinous neoplasm. The remaining 10 patients did not require further PD drainage (clinical success rate 52%). Conclusions These preliminary results show that BD-SESs are safe to use and able to resolve fibrotic PD strictures in CP. These encouraging outcomes warrant further testing. [ABSTRACT FROM AUTHOR]

To date, surveillance of high-risk individuals for pancreatic ductal adenocarcinoma (PDAC) has not lived up to expectations, as identification of curable stages through imaging remains challenging. Biomarkers are therefore needed. Pancreatic juice (PJ) may be a promising source, because it is in direct contact with the ductal epithelial lining from which PDAC arises. We aimed to develop a panel of biomarkers from serum and PJ to detect PDAC for future surveillance purposes. All patients who underwent PJ collection on secretin stimulation at the Erasmus MC were included. Both PJ and serum were evaluated. Protein levels were determined by the Lowry assay. Potential biomarkers (interleukin-8, interferon-γ, neutrophil gelatinase-associated lipocalin [NGAL], mucin 5, subtype AC [MUC5AC], mucin 2, phospholipase A 2 group IB) were selected based on previously reported outcomes and assessed with enzyme-linked immunosorbent assay. Serum carbohydrate antigen 19-9 (CA19-9) values were determined by electrochemiluminescence immunoassay. This study included 59 cases and 126 surveilled control subjects (who underwent PJ collection), of whom 71 had a hereditary predisposition (35 genetic, 36 familial) and 55 had (suspected neoplastic) pancreatic cysts. CA19-9 values were available for 53 cases and 48 control subjects. Serum CA19-9, as well as PJ interleukin-8, NGAL and MUC5AC, were associated with PDAC independent of age, gender, and presence of diabetes mellitus. Serum CA19-9 had a significantly higher area under the curve (AUC;.86; 95% confidence interval [CI],.79-.94) than individual PJ markers (AUC,.62-.70). A combination of PJ markers and serum CA19-9 (panel 2: sensitivity 42% [95% CI, 29-57] and specificity 96% [95% CI, 86-100]) did not improve diagnostic performance compared with CA19-9 alone (sensitivity 70% [95% CI, 56-82] and specificity 85% [95% CI, 72-94]). High levels of serum CA19-9 and PJ-derived proteins are associated with PDAC. Prospective surveillance studies including individuals at risk of developing PDAC are required to validate these findings. [Display omitted] [ABSTRACT FROM AUTHOR]

Background The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. Objective To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. Design Multicenter, retrospective study. Setting Multiple, international, academic centers. Patients Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. Interventions OTSC placement to attempt closure of GI defects. Main Outcome Measurements Long-term success of the procedure. Results A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) ( P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). Limitations Retrospective design and multiple operators with variable expertise with the OTSC device. Conclusion OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure. [ABSTRACT FROM AUTHOR]

Background: Fully-covered self expandable metal stents (fcSEMSs) are an alternative to progressive plastic stenting for the treatment of benign biliary strictures (BBS) with the prospect of a higher treatment efficacy and the need for fewer ERCPs, thereby reducing the burden for patients and possibly costs. Key to this novel treatment is safe stent removal. Objective: To investigate the feasibility and safety of stent removal of a fcSEMS with a proximal retrieval lasso: a long wire thread integrated in the proximal ends of the wire mesh that hangs freely in the stent lumen. Pulling it enables gradual removal of the stent inside-out. A secondary aim was success of stricture resolution. Design: Non-randomized, prospective follow-up study with 3 sequential cohorts of 8 patients with BBS. Setting: Academic tertiary referral center. Patients: Eligible patients had strictures either postsurgical (post-cholecystectomy (LCx) or liver transplantation (OLT)), due to chronic pancreatitis (CP), or papillary stenosis (PF). Strictures had to be located at least 2 cm below the liver hilum. All patients had one plastic stent in situ across the stricture and had not undergone previous treatment with either multiple plastic stents or fcSEMS. Interventions: The first cohort of patients underwent stent placement for 2 months, followed by 3 months if the stricture had not resolved. The second and third cohort started with 3 months and 4 months, respectively, both followed by another 4 months if indicated. Treatment success was defined by stricture resolution at cholangiography, the ability to pass an inflated extraction balloon and clinical follow-up (at least 6 months). Main outcome measurement: safety of stent removal. Secondary outcomes were complications and successful stricture resolution. Results: A total of 23 patients (11 female; 20-67 yrs) were eligible for final analysis. One patient developed a malignant neuroendocrine tumor in the setting of CP. Strictures were caused by CP (13), OLT (6), LCx (3) and PF (1). In total 39 fcSEMS were placed and removed. Removals were easy and without complications. Transient pain after insertion was common (13 of 23/56%) but was easily managed by analgesics in all patients. Other complications were cholecystitis (1), cholangitis due to stent migration (1, stent replaced) or stent clogging (2, managed endoscopically) and worsening of CP (2). In these patients, the fcSEMS was removed and replaced after pancreatic sphincterotomy and PD stent placement. Median follow-up was 15 months (range 11-25). Overall treatment success was 61% (14/23); in the CP group 46%, in the remaining patients 80% (p = 0.11). Patients with stricture resolution after removal of the first stent (n = 7; success 6/7) showed a trent towards a more sustained treatment success than patients who needed a 2nd stent placement (n = 16; success 8/16); p = 0.12). Limitations: Small number of patients with regard to secondary outcomes. Conclusion: Removal of a new type of fcSEMS with a proximal retrieval lasso in patients with BBS proved easy and uncomplicated. Treatment success for CP strictures was higher compared to what is known from results of progressive plastic stenting protocols. For other indications treatment success was comparable to progressive plastic stenting, but with the prospect of fewer ERCP procedures. [ABSTRACT FROM AUTHOR]

Background: Most benign biliary strictures nowadays are managed endoscopically with plastic stents or with a insertion of a fully covered self-expandable metal stent (fcSEMS). The paradigm for the treatment of benign hilar strictures precludes the use of an fcSEMS because it obstructs the intrahepatic bile ducts, in particular, the contralateral hepatic duct. It is unknown whether use of a plastic stent in the opposite hepatic duct after deployment of an fcSEMS across the liver hilum provides an adequate solution for this problem. Objective: To evaluate the use of an fcSEMS in combination with a contralateral plastic stent in the treatment of benign hilar strictures. Design: Case series. Setting: Tertiary referral hospital. Patients: Two consecutive patients with benign hilar strictures. Interventions: Placement of an intrahepatically deployed fcSEMS in conjunction with a contralateral 10F plastic stent for 4 to 5 months followed by stent removal and cholangiogram. Main Outcome Measurements: Clinical and laboratory follow-up of at least 9 months. Results: In both patients, the indwelling period of the stents was uneventful as was stent removal. Both strictures resolved, and there were no clinical or biochemical signs of a recurrent stricture. Limitations: Small number of patients. Conclusions: Treatment of benign hilar strictures with an fcSEMS deployed across the liver hilum in conjunction with a contralateral plastic stent placement is feasible without ensuing cholangitis caused by bile duct occlusion. [Copyright &y& Elsevier]

Background: EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist. Objective: To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device. Design: Multicenter, pooled, cohort study. Setting: Five medical centers. Patients: This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes. Intervention: EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device. Main Outcome Measurements: Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis. Results: We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively. Limitations: Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses. Conclusion: Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%. [Copyright &y& Elsevier]

Background & Aims: Two percent to 4% of all cases of colorectal cancer (CRC) are associated with Lynch syndrome. Dominant clustering of CRC (non-Lynch syndrome) accounts for 1%–3% of the cases. Because carcinogenesis is accelerated in Lynch syndrome, an intensive colonoscopic surveillance program has been recommended since 1995. The aim of the study was to evaluate the effectiveness of this program. Methods: The study included 205 Lynch syndrome families with identified mutations in one of the mismatch repair genes (745 mutation carriers). We also analyzed data from non-Lynch syndrome families (46 families, 344 relatives). Patients were observed from January 1, 1995, until January 1, 2009. End points of the study were CRC or date of the last colonoscopy. Results: After a mean follow-up of 7.2 years, 33 patients developed CRC under surveillance. The cumulative risk of CRC was 6% after the 10-year follow-up period. The risk of CRC was higher in carriers older than 40 years and in carriers of MLH1 and MSH2 mutations. After a mean follow-up of 7.0 years, 6 cases of CRC were detected among non-Lynch syndrome families. The risk of CRC was significantly higher among families with Lynch syndrome, compared with those without. Conclusions: With surveillance intervals of 1–2 years, members of families with Lynch syndrome have a lower risk of developing CRC than with surveillance intervals of 2–3 years. Because of the low risk of CRC in non-Lynch syndrome families, a less intensive surveillance protocol can be recommended. [Copyright &y& Elsevier]

Background: Peutz-Jeghers syndrome (PJS) is a hereditary disorder characterized by mucocutaneous pigmentations and hamartomatous polyps mainly in the small bowel. These polyps may cause complications such as intussusception. Objective: To assess therapeutic efficacy and safety of double-balloon enteroscopy (DBE) for detection and treatment of small-bowel polyps in patients with PJS. Design: Prospective cohort study. Setting: Tertiary-care referral center. Patients: This study involved 13 patients with PJS, defined as a proven STK11 gene mutation or according to international diagnostic criteria. Intervention: DBE with enteroscopic removal of pedunculated polyps of ≥10 mm. Main Outcome Measurements: Location, number and size of small-bowel polyps, polypectomy data, and complications and long-term complications associated with development of small-intestine polyps. Results: Thirteen patients with PJS (8 male, mean age 31 years) underwent 29 DBE procedures. Ten patients (77%) had a history of partial small-bowel resection because of small-bowel polyps. Small-bowel polyps were found in all 13 patients. The majority of polyps (94%) were located in the proximal jejunum. A total of 82 polyps of ≥10 mm were detected, and 79 (96%) were endoscopically removed without complications. After the introduction of DBE, no small-intestine-polyp-related complications occurred during a follow-up period of 356 person-months. Limitations: Small number of patients. Conclusion: DBE is clinically useful and safe for diagnosis and therapy of small-bowel polyps in patients with PJS, even in patients with a history of extensive abdominal surgery. DBE may decrease the need for laparotomy in patients with PJS. [Copyright &y& Elsevier]

Pancreatoscopy-guided electrohydraulic lithotripsy (EHL) has shown potential in the treatment of patients with obstructive chronic calcifying pancreatitis (CCP). We aimed to prospectively investigate the efficacy and safety of EHL as first-line therapy in patients with CCP of the pancreatic duct (PD). A prospective single-center consecutive case series was performed including symptomatic CCP patients with obstructing stones >5 mm in the head or neck of the pancreas. Stone fragmentation was performed using EHL. Primary study outcome was technical success. Secondary outcomes were clinical success, adverse events, and number of interventions. Thirty-four consecutive patients were included. Complete or partial stone clearance after EHL was achieved in 24 patients (70.6%). Pancreatoscopy was not performed because of failure to cannulate the PD (n = 5) or resolution of stones after stent placement at the index endoscopic retrograde pancreaticography (ERP) procedure (n = 3). After successful PD cannulation, pancreatoscopy was technically successful in 24 of 26 patients (92.3%). In 1 patient, the stone could not be visualized because of a resilient stricture. Complete stone clearance was achieved in 20 patients (80%) and partial clearance in 5 patients (20%), after a median of 2 ERP procedures (interquartile range, 2) and 1 EHL procedure (interquartile range, 1). In patients who underwent pancreatoscopy with EHL, mean Izbicki pain score at baseline was 62.3 ± 23.1 (25/25) and dropped significantly to 27.5 ± 35.0 (22/25) at the 6-month follow-up (P <.001). The most common adverse event was acute pancreatitis, all mild and treated conservatively (n = 7). Pancreatoscopy-guided EHL is a promising treatment for symptomatic CCP patients with obstructive PD stones. (Clinical trial registration number: NTR6853.) [ABSTRACT FROM AUTHOR]

To successfully implement imaging-based pancreatic cancer (PC) surveillance, understanding the timeline and morphologic features of neoplastic progression is key. We aimed to investigate the progression to neoplasia from serial prediagnostic pancreatic imaging tests in high-risk individuals and identify factors associated with successful early detection. We retrospectively examined the development of pancreatic abnormalities in high-risk individuals who were diagnosed with PC or underwent pancreatic surgery, or both, in 16 international surveillance programs. Of 2552 high-risk individuals under surveillance, 28 (1%) developed neoplastic progression to PC or high-grade dysplasia during a median follow-up of 29 months after baseline (interquartile range [IQR], 40 months). Of these, 13 of 28 (46%) presented with a new lesion (median size, 15 mm; range 7–57 mm), a median of 11 months (IQR, 8; range 3–17 months) after a prior examination, by which time 10 of 13 (77%) had progressed beyond the pancreas. The remaining 15 of 28 (54%) had neoplastic progression in a previously detected lesion (12 originally cystic, 2 indeterminate, 1 solid), and 11 (73%) had PC progressed beyond the pancreas. The 12 patients with cysts had been monitored for 21 months (IQR, 15 months) and had a median growth of 5 mm/y (IQR, 8 mm/y). Successful early detection (as high-grade dysplasia or PC confined to the pancreas) was associated with resection of cystic lesions (vs solid or indeterminate lesions (odds ratio, 5.388; 95% confidence interval, 1.525–19.029) and small lesions (odds ratio, 0.890/mm; 95% confidence interval 0.812–0.976/mm). In nearly half of high-risk individuals developing high-grade dysplasia or PC, no prior lesions are detected by imaging, yet they present at an advanced stage. Progression can occur before the next scheduled annual examination. More sensitive diagnostic tools or a different management strategy for rapidly growing cysts are needed. Almost half of pancreatic cancers develop rapidly and without warning signs on scans or endoscopy. The other half grow from earlier visible pancreatic cysts, which are difficult to discern from innocent cysts. [ABSTRACT FROM AUTHOR]

Background: ERCP on an outpatient basis could be as safe as on an inpatient basis and may also reduce medical costs. Objective: To review the available literature to determine the safety of an ERCP performed on an outpatient basis. Design: A review of the published literature was performed by searching PubMed, the Cochrane Library, EMBASE, and the Web of Science. Patients: Patients who were undergoing an ERCP. Interventions: An ERCP on an inpatient or outpatient basis. Main Outcome Measurements: Patient and treatment characteristics, complications, and prolonged hospital admissions and readmissions. Results: Eleven studies were included in this review, of which 5 were comparative studies, 5 were prospective studies, and 1 was a retrospective study. In these series, a total of 2483 patients underwent an ERCP on an outpatient basis and 2320 patients were admitted overnight after an ERCP. Complications were seen in 184 of 2483 outpatients (7%), of which 72% of complications (107/149) presented within 2 to 6 hours, 10% (15/149) within 6 to 24 hours, and 18% (27/149) more than 24 hours after the ERCP. Three percent of the inpatients (82/2320) developed a complication, of which 95% of complications (78/82) presented within 24 hours and 5% (4/82) presented more than 24 hours after the ERCP. A prolonged hospital stay after an ERCP was indicated in 6% of the designated outpatients (148/2483), whereas 3% of outpatients (74/2149) and <1% of inpatients (4/2320) were readmitted after discharge. Limitations: Limited data available. Conclusions: This review shows that, with a selective policy, an ERCP on an outpatient basis seems as safe as when performed on an inpatient basis. [Copyright &y& Elsevier]

Background: It is well known that a learning curve exists for performing EUS. Objective: To determine whether the number of EUS investigations performed in a center affects the results of esophageal cancer staging. Design: We compared EUS in the evaluation of T stage and the presence of regional and celiac lymph nodes in a low-volume center where <50 EUS/endoscopist/y were performed with reported results from 7 high-volume EUS centers. Setting: A reference center for esophageal cancer (>90 cases/y) but a low-volume center for EUS when it comes to individual endoscopists. Patients: From 1994 to 2003, 244 patients underwent EUS, without specific measures to pass a stenotic tumor or FNA and with postoperative TNM stage as the criterion standard in the low-volume EUS center. In the high-volume centers, 670 EUS investigations for esophageal cancer were performed, if needed, with dilation, and with postoperative TNM stage and/or FNA as the criterion standard. Interventions: Retrospective analysis. Main Outcome Measurements: Sensitivity and specificity of EUS for esophageal cancer staging. Results: In the low-volume center, results of EUS for T3 staging in patients in whom passage of the EUS probe was possible were almost comparable for sensitivity (85% vs 88%-94%) but were lower for specificity (57% vs 75%-90%), whereas both sensitivity (58% vs 75%-90%) and specificity (87% vs 94%-97%) for T1 or T2 stages were lower than those reported in the high-volume centers. In the low-volume center, sensitivities of EUS for regional (45% vs 63%-89%) and celiac (19% vs 72%-83%) lymph nodes were lower, whereas specificities (75% vs 63%-82% and 99% vs 85%-100%, respectively) were comparable with those from high-volume centers. Results in the low-volume EUS center were worse if the EUS probe could not pass the stricture, which occurred in almost 30% of patients. Limitations: Both FNA and dilation before EUS for stenotic tumors were not performed in the low-volume EUS center. Conclusions: The results of EUS performed in a low-volume EUS center compared unfavorably with those reported from high-volume EUS centers. The results of this study suggest that preoperative staging by EUS should be performed by experienced and dedicated EUS endoscopists to optimize staging of esophageal cancer. [Copyright &y& Elsevier]

The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P =.396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P <.001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P =.021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P <.0001). EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.) [Display omitted] [ABSTRACT FROM AUTHOR]

The recent development of microforceps for EUS through-the-needle biopsy (TTNB) sampling of the wall of pancreatic cystic lesions (PCLs) allows the collection of histologic specimens never handled and evaluated before by pathologists. We aimed to estimate the interobserver agreement among pathologists in evaluating such samples. TTNB specimen slides from 40 PCLs with worrisome features were retrieved and independently evaluated for specimen adequacy, presence of lining epithelium, grade of epithelial dysplasia, presence of ovarian type stroma, and specific diagnosis by 6 expert pathologists from 6 different tertiary care centers. The Gwet's AC1 was used to assess interobserver agreement. An almost perfect agreement was observed for specimen adequacy (AC1,.82; 95% confidence interval [CI],.79-.98), presence of lesional epithelium (AC1,.90; 95% CI,.86-.92), epithelial dysplasia (AC1,.97; 95% CI,.95-.99), and ovarian-like stroma (AC1,.90; 95% CI,.86-.93). When considering all diagnoses separately, a moderate to substantial agreement was observed (AC1,.62; 95% CI,.57-.67), similarly to mucinous cysts versus serous adenoma versus other diagnoses (AC1,.65; 95% CI,.59-.70) and for mucinous cysts versus all other diagnoses (AC1,.74; 95% CI,.68-.84). The agreement for diagnosis of mucinous cystic neoplasm versus intraductal mucinous papillary neoplasm was almost perfect (AC1,.88; 95% CI,.81-.95). Interobserver agreement between expert pathologists in the evaluation of TTNB samples from PCLs with worrisome features was close to perfection for all evaluated parameters, except definitive diagnosis. When mucinous cystic lesions were compared versus all other diagnoses, the agreement became substantial, thus indicating that TTNB specimens can provide important information for PCL management decisions. [ABSTRACT FROM AUTHOR]