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Background and Aims: Although the efficacy of palliative bilateral biliary drainage using self-expandable metal stents has been demonstrated, it is unclear which bilateral method is optimal for advanced malignant hilar biliary strictures (MHSs). This pilot study compared bilateral stent-in-stent (SIS) with stent-by-stent (SBS) deployment for advanced MHSs., Methods: Patients with inoperable high-grade MHSs were enrolled in this prospective randomized multicenter study. The primary outcome was the rate of adverse events, whereas secondary outcomes were technical and clinical success, reintervention, therapeutic outcomes, stent patency, and survival duration., Results: This study randomized 69 of 74 pathologically diagnosed patients to the SIS (n = 34) or SBS (n = 35) groups. The total adverse event rate after stent deployment did not differ between the 2 groups (23.5% in the SIS group vs 28.6% in the SBS group, P = .633). The primary technical success rate was 100% (34/34) and 91.4% (32/35) in the SIS and SBS groups, respectively (P = .081). The clinical success rate was 94.1% (32/34) and 90.6% (29/32), respectively (P = .668). The stent patency rate at 3 months was 85.3% in the SIS group and 65.7% in the SBS group (P = .059). At 6 months, the stent patency rate was 47.1% and 31.4%, respectively (P = .184). The median cumulative stent patency and survival probability did not differ between the 2 groups., Conclusions: Efficacy of bilateral SIS and SBS deployment may be similar in terms of total adverse events, technical and clinical success, stent patency, and survival. The stent patency rates at 3 and 6 months was higher in the SIS group without statistical difference. (Clinical trial registration number: NCT01141088.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) has a high diagnostic accuracy for pancreatic tumors. Most reports have focused on the diagnostic yield of cytology or histology; the ability of various FNA/B techniques to obtain an adequate mass of cells or tissue has rarely been investigated., Methods: Patients with suspected pancreatic malignancy underwent EUS-FNB using a 22-gauge ProCore needle by either the stylet slow-pull-back technique (group A), conventional negative suction after stylet removal (group B), or non-suction after stylet removal (group C) in the absence of an on-site cytopathologist. The adequacy of the 3 techniques based on the diagnostic yield, cellularity, blood contamination, and core-tissue acquisition was evaluated., Results: A total of 50 patients (27 males) were analyzed. The mean tumor size was 21 to 40 mm in 54%. The rate of a good or excellent proportion of cellularity was highest in group A compared with groups B and C (72% vs 60% vs 50%, P = .049). A >25% rate of blood contamination was more prevalent in group B (30% vs 42% vs 10%, P = .009). The rate of adequate core-tissue acquisition was not different (52% vs 34% vs 50%, P = .140). Based on the multivariate generalized estimation equation, the stylet slow-pull-back technique and a tumor size >40 mm were favorable factors for diagnostic adequacy., Conclusions: The stylet slow-pull-back technique might enable acquisition of tissue and assessment of cellularity for the diagnosis of pancreatic tumors suspected to be malignant. (Clinical trial registration number: KCT0002190.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Appropriate colonoscopy withdrawal times for individual colonic segments are not well known. The relationship between withdrawal time and adenoma detection rate (ADR)/polyp detection rate (PDR) in individual colonic segments was examined in this study., Methods: This was a prospective observational study involving 724 patients who underwent colonoscopy screening or surveillance colonoscopy from October 2015 to February 2017 at 10 university hospitals., Results: In the right side of the colon, the ADR (33.2% vs 13.7%, P < .001), PDR, serrated polyp detection rate, and number of adenomas per colonoscopy (APC) were significantly higher when the colonoscopy withdrawal time was ≥2 minutes compared with <2 minutes. When the withdrawal time was ≥4 minutes in the proximal colon and ≥3 minutes in the left segment of the colon, the ADR, PDR, and APC were significantly higher compared with withdrawal times of <4 minutes and <3 minutes, respectively. Multivariate analyses showed that the ADR was significantly associated with withdrawal times of ≥2 minutes in the right side of the colon (odds ratio [OR], 2.98; 95% confidence interval [CI], 1.72-5.15; P < .001), ≥4 minutes in the proximal colon (OR, 4.48; 95% CI, 3.15-6.36; P < .001), and ≥3 minutes in the left segment of the colon (OR, 2.92; 95% CI, 1.74-4.91; P < .001)., Conclusions: The PDR and ADR appeared to be significantly increased when the withdrawal time was ≥2 minutes in the right-sided colon segment, ≥4 minutes in the proximal colon, and ≥3 minutes in the left-sided colon segment compared with shorter withdrawal times., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs., Methods: Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration., Results: A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively (P = .244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively (P = .047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group (P = .049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P < .01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P < .001). Survival probability and late adverse events were not different between the 2 groups., Conclusions: Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: No reported prospective, randomized study has evaluated the impact of an endoscopy nurse participating as a second observer during colonoscopy., Objective: To determine whether the participation of an endoscopy nurse enhanced the polyp detection rate (PDR) and adenoma detection rate (ADR) during screening colonoscopy., Design: Multicenter, prospective, randomized study., Setting: Academic hospitals., Patients: A total of 844 consecutive patients undergoing screening colonoscopy., Interventions: Single observation by colonoscopist or dual observation by colonoscopist and endoscopy nurse during colonoscope withdrawal., Main Outcome Measurements: PDR and ADR., Results: No significant difference in patient demographic data, adequacy of bowel preparation, or mean withdrawal time was observed between the 2 groups. In total, 1153 polyps, including 762 adenomas, were detected in 791 patients. Seven nonpolypoid, depressed neoplastic lesions (0-IIc or combined types) were only detected in the dual observation group. A multivariate analysis revealed that experienced (≥ 2 years) endoscopy nurse participation significantly increased the PDR and ADR compared with those in the single observation group by a colonoscopist alone (adjusted odds ratio [OR] 1.58 [95% CI, 1.07-2.32]; adjusted OR 1.47 [95% CI, 1.01-2.12], respectively). Additionally, the PDR was significantly higher in the dual-observation group with fellows (<500 colonoscopies) and an experienced endoscopy nurse versus that in the single observation group (adjusted OR 2.07 [95% CI, 1.15-3.74]). There was no significant benefit of experienced nurse participation in the subgroup with experienced colonoscopists., Limitations: Absence of colonoscopist blinding., Conclusions: Experienced endoscopy nurse participation increased the PDR and ADR during screening colonoscopy. However, the benefit of participation by experienced nurses appears to be exclusively with inexperienced colonoscopists., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Digital chromoendoscopy (DCE) has the potential for the in vivo optical diagnosis of colon polyps. However, no comparison of different DCE technologies currently exists., Objective: To compare the diagnostic efficacies of narrow-band imaging (NBI) with those of I-Scan for the real-time histological prediction of diminutive colonic polyps (DCPs) (≤5 mm) by using the simple unified endoscopic classification., Design: Prospective cohort study., Setting: Academic hospital., Patients: In total, 296 DCPs from 142 patients undergoing screening or surveillance colonoscopy were assessed., Interventions: All DCPs detected during withdrawal were evaluated for the surface details by using high-definition white-light colonoscopy, and thereafter by using DCE (NBI or I-Scan) without optical magnification. The histology of all polyps was predicted in real-time and confirmed through the evaluation of biopsy or polypectomy specimens., Main Outcome Measurements: Diagnostic efficacies of NBI and I-Scan., Results: NBI and I-Scan displayed a significantly higher sensitivity and improved accuracy compared with high-definition white-light colonoscopy for the prediction of adenomas (P < .05). No significant differences were evident between the NBI and I-Scan (sensitivity, 88.8% vs 94.6%; specificity, 86.8% vs 86.4%; accuracy, 87.8% vs 90.7%, respectively; P > .05). Additionally, substantial levels of intra- and interobserver agreement between the NBI and I-Scan were measured (κ values >0.7)., Limitations: No randomized or crossover design., Conclusions: NBI and I-Scan displayed a similar efficacy for the real-time histological prediction of DCPs. The simple unified endoscopic classification can be used for the interpretation of DCE, regardless of the type of technology. (, Clinical Trial Registration Number: NCT1133041.)., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Despite advances in imaging, differentiating benign from malignant causes of pancreatic duct dilation is difficult., Objective: The aim of our study was to assess the accuracy of the periductal hypoechoic sign (PHS), defined as patchy hypoechoic areas adjacent to a dilated pancreatic duct, for the diagnosis of pancreatic malignancy., Design: Single-center, retrospective analysis., Setting: Tertiary care university hospital., Patients: All patients who underwent EUS from 2006 to 2008 for evaluation of pancreatic pathology were identified. Those with pancreatic duct dilation of 4 mm or more in the head of the pancreas or 3 mm or more in the body or tail were included. Digitally recorded EUS images were analyzed for PHS by 1 endoscopist blinded to final results. The final diagnosis was based on pathology results or clinical follow-up., Results: During the study period, 84 of 427 patients who underwent EUS for pancreas pathology had dilated pancreatic ducts. Of these, 42 patients had benign disease and 42 had pancreatic malignancy. The PHS was noted in 31 (73.8%) of 42 patients with malignancy compared with 6 (14.3%) of 42 patients with benign disease (P < .001). The PHS had a sensitivity of 73.8%, a specificity of 85.7%, and an accuracy of 79.8% for the diagnosis of pancreatic malignancy. After adjusting for age, patients with the PHS were 17 times more likely to have a malignancy (odds ratio 16.66; 95% CI, 5.01-55.44). Pancreatic duct diameter or dilation of both bile and pancreatic ducts were not predictive of malignancy., Limitation: A retrospective design., Conclusions: The PHS was an accurate and independent predictor of pancreatic malignancy in patients with a dilated pancreatic duct.

Background: The technique of endoscopic submucosal dissection (ESD) was introduced to be able to obtain en bloc specimens of large early GI neoplasms. The drawback of ESD is its technical difficulty, which, consequently, is associated with a higher rate of complication and which requires advanced endoscopic techniques and a long procedure time., Objective: To assess the therapeutic outcome of ESD by expert endoscopists who have at least 3 years' experience of EMR in Korea., Design: A retrospective, multicenter study., Patients: From January 2006 to June 2007, 1000 early gastric cancers in 952 patients (502 men, 450 women; mean age 62.1 years, range 43-90 years) were treated by using ESD at 6 Korean ESD study group (KESG)-related university hospitals in Korea., Intervention: We performed ESD procedures with typical sequences (marking, incision, and submucosal dissection)., Main Outcome Measurements: The rate of en bloc resection, incidence of complication, and length of procedure. Predetermined factors (various endoscopic and final pathologic features) for these outcomes., Results: The rates of en bloc resection, complete en bloc resection, vertical incomplete resection, and piecemeal resection were 95.3%, 87.7%, 1.8%, and 4.1%, respectively. The rates of delayed bleeding, significant bleeding, perforation, and surgery related to complication were 15.6%, 0.6%, 1.2%, and 0.2%, respectively. The mean procedure time was 47.8 +/- 38.3 minutes. The rates of en bloc resection differed significantly in relation to the location of the lesions (upper portion vs middle portion vs lower portion of the stomach, 88.6% vs 95.2% vs 96.0%, respectively; P = .02), presence of a scar (no vs yes, 96.0% vs 89.5%, respectively; P = .002), and histologic type (low-grade adenoma vs high-grade adenoma vs differentiated early gastric cancer vs undifferentiated early gastric cancer, 95.8% vs 94.6% vs 96.2% vs 83.8%, respectively; P = .007). The rates of delayed bleeding differed significantly in relation to location (upper portion vs lower portion of the stomach, 28.6% vs 13.8%, respectively; P = .003), the size of the tumor (>40 mm vs <20 mm, 28.6% vs 13.7%, respectively; P = .009), recurrent lesion (29.4% vs 15.1%, respectively; P = .024), and macroscopic type (flat vs elevated, 18.8% vs 12.4%, respectively; P = .047). Factors related to the longer procedure time were location (upper portion vs lower portion of the stomach, 64.8 vs 44.1 minutes, respectively; P < .001), the size of the tumor (>40 mm vs < 20 mm, 67.1 vs 42.0 minutes, respectively; P < .001), the presence of ulcer (54.6 vs 46.8 minutes; P < .045), and the presence of a scar (69.2 vs 45.0 minutes; P < .001)., Conclusions: ESD is an effective and safe therapy in the management of early gastric neoplasms. Endoscopists have to accept the need for advanced endoscopic techniques for performing ESD in the case of large lesions, scar lesions, undifferentiated cancers, or for the lesions in the upper portion of the stomach. Endoscopists require more experience to decrease complications in patients who have a large or recurrent lesion in the upper portion of the stomach; these lesions also take more time to complete the ESD procedure.

Background: Various training programs in colonoscopy recommend that trainees should perform at least 100 to 200 procedures to be considered technically competent at diagnostic colonoscopy., Objective: Our purpose was to determine the adequate level of training for technical competence in screening and diagnostic colonoscopy., Design: A prospective multicenter trial., Setting: Fifteen tertiary care academic medical centers., Patients: Over 8 months we prospectively evaluated the procedures of 24 first-year GI fellows in 15 tertiary care academic medical centers. A total of 4351 colonoscopies were assessed prospectively with variable clinical factors., Intervention: Cecal intubation was documented by photographing the identified cecal landmarks, including the appendiceal orifice and the ileocecal valve., Main Outcome Measurements: Acquisition of competence (success rate) was evaluated for colonoscopic training on the basis of 2 objective criteria: (1) adjusted completion rate (>90%) and (2) cecal intubation time (<20 minutes)., Results: The overall success rate was 83.5% (3635/4351). The mean cecal intubation time was 9.23 +/- 4.63 minutes. The success rate significantly improved and reached the requisite standard of competence after 150 procedures (71.5%, 82.6%, 91.3%, 94.4%, 98.4%, and 98.7%, respectively, for every 50 consecutive blocks). The polyp detection rate did not improve significantly during the 8 months and was not correlated with the learning curve. In addition, mean time to cecal intubation decreased significantly, from 11.16 to 8.39 minutes, after 150 procedures. Logistic regression analysis found that prolonged cecal intubation was caused by the following factors: elderly patients, female sex, low body mass index, poor bowel preparation, poor American Society of Anesthesiologists status, abdominal pain as an indication, instructor's supervision, and low case volume., Limitations: We did not record final pathologic reports of detected polyps and withdrawal time., Conclusions: Competence in technically efficient screening and diagnostic colonoscopy generally requires experience with more than 150 cases. Also, factors associated with prolonged cecal intubation for typical trainees did not differ from those for experienced colonoscopists.