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Background and Aims: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions., Methods: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens., Results: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis., Conclusions: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.)., Competing Interests: Disclosure G. Costamagna: Research grants from Cook Medical, Olympus, and Boston Scientific. L. Petruzziello: Research grants from Cook Medical, Olympus, and Boston Scientific. D. L. Diehl: Consultant for Boston Scientific, Olympus, Pentax, Microtech, Steris, Castle Biosciences, Laborie, Actuated Medical, Lumendi, Merit Medical, and One Pass Medical. A. May: Study support from Interscope. A. Repici: Consultant for Boston Scientific, Fujifilm, and ERBE. R. Maselli, Consultant for Boston Scientific, Fujifilm, ERBE, 3D Matrix, and Apollo Endosurgery. All other authors disclosed no financial relationships. The study was sponsored by Interscope, Inc., (Copyright © 2024. Published by Elsevier Inc.)

Background and Aims: A biological papilla made of chicken heart tissue, incorporated into the Boškoski-Costamagna ERCP Trainer simulator, was recently designed to allow training in sphincterotomy. This study aimed to evaluate the face and content validity of this tool., Method: Participants from 2 groups (nonexperienced and experienced [<600 or >600 lifetime ERCPs, respectively]) were invited to perform standardized assignments on the model: sphincterotomy and precut for both groups and papillectomy for the experienced group. Following these assignments, all participants filled out a questionnaire to rate their appreciation of the realism of the model, and experienced endoscopists were also asked to evaluate its didactic value using a 5-point Likert scale., Results: A total of 19 participants were included (nonexperienced, n = 10; experienced, n = 9). Parameters regarding the realism of the tool in terms of general appearance, sphincterotomy, precut, and papillectomy were overall considered realistic (4 of 5), with good agreement rates in terms of overall realism between groups. Experienced operators reported the highest realism for "positioning the scope and needle-knife in the field of view" and "during precut," "cutting in small increments during precut," and "controlling the scope during papillectomy," and they highly agreed that this papilla should be included for training novice and intermediate trainees in sphincterotomy, precut, and papillectomy., Conclusions: Our results show good face validity and excellent content validity of this biological papilla combined with the Boškoski-Costamagna ERCP Trainer. This new tool provides a useful, inexpensive, versatile, and easy tool for training regarding sphincterotomy, precut, and papillectomy. Future studies should explore whether including this model in real-life training improves the learning curve of endoscopy trainees., Competing Interests: Disclosure The following authors disclosed financial relationships: I. Boskoski: Consultant for Apollo Endosurgery, Boston Scientific, Cook Medical, Pentax, Nitinotes, EndoTools; Research grants from Apollo Endosurgery, Erbe Elektromedizin, EndoTools; Sponsored lectures for Cook Medical, Boston Scientific, Apollo Endosurgery, Microtech, Olympus; Patents for USA No: US D740,361 S (Endoscopy Training Apparatus) Oct. 6, 2015; Stent for electrothermal treatment, Patent No: 0001426680, Class A61B1814 – Feb. 7, 2017. G. Costamagna: Cook Medical. T. Voiosu: Honoraria for educational events and travel grant from Cook Medical; honoraria for educational events from Boston Scientific. All other authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain., Methods: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent., Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65)., Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process., Methods: Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement., Results: Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%)., Conclusions: This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: 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., Methods: 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)., Results: 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)., Conclusions: 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.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The abrupt outbreak of the novel coronavirus disease 2019 and its rapid spread over many healthcare systems throughout the world has led to a shortage in personal protective equipment (PPE), which cannot be solved by reducing their use or by increasing production. It is thus necessary to promote PPE rational use, highlighting possible differences in terms of efficacy and promoting an effective technique to reuse them., Methods: A literature search was performed on PubMed, Scopus, Cochrane database, and Google Scholar, and from the 25 top cited articles, 15 were selected for relevance and impact., Results: Most studies on previous respiratory virus epidemics to date suggest surgical masks are not inferior compared with N95 respirators in terms of protective efficacy among healthcare workers. Therefore, the use of N95 respirators should be limited to high-risk situations. Concerning respirator reuse, highly energetic, short-wave, ultraviolet germicidal irradiation (UVGI) at 254 nm was determined to decontaminate N95 respirators from viral respiratory agents, but UVGI requires careful consideration of the type of respirator and of the biologic target., Conclusions: Rational use and successful reuse of respirators can help in the shortage of PPE during a pandemic. Further studies testing UVGI and other decontamination techniques are an unmet need. The definitive answer to pandemic issues can be found in artificial intelligence and deep learning. These groundbreaking modalities could help in identifying high-risk patients and in suggesting appropriate types and use of PPE., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Right aberrant hepatic ducts are an anatomic variant with clinical relevance because of the risk of injury during cholecystectomy. Treatment options for aberrant hepatic duct injuries are not standardized. This study aims to analyze the long-term results of endoscopic treatment of aberrant hepatic duct lesions., Methods: Patients who underwent ERCP for aberrant hepatic duct lesions were retrospectively identified. Demographic data, type of aberrant duct lesion according to the Strasberg classification, type of treatment (number of plastic stents inserted, treatment duration, and number of ERCPs), and adverse events were recorded. Follow-up was obtained by telephone contact or medical examinations., Results: Between January 1996 and March 2019, 32 patients (78% women, mean age 51.7 years) with aberrant hepatic duct injuries underwent ERCP at our Endoscopy Unit. Six patients had Strasberg type B lesions, 11 patients had type C, and 8 patients had type E5, and 7 patients had a stenosis of the aberrant duct. A mean of 3.7 biliary plastic stents per patient were used; mean treatment duration was 6.3 months. All patients with isolated aberrant duct stenosis and 1 of 6 patients (17%) with type B Strasberg lesions achieved patency. Ten of 11 patients (91%) with type C Strasberg lesions achieved duct recanalization. After a mean follow-up of 109.3 ± 61.2 months, 29 of 32 patients (91%) were asymptomatic; 1 underwent surgery for recurrent cholangitis, 1 received a new endoscopic procedure because of cholangitis, and 1 reported episodic biliary colic without an increase in liver function test values and was successfully managed with a low-fat diet., Conclusions: An endoscopic approach to aberrant hepatic duct lesions after cholecystectomy can be considered an effective first-line therapy., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal., Methods: In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell., Results: One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence., Conclusion: In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.)., (Copyright © 2020. Published by Elsevier Inc.)

Background and Aims: Second-generation colon capsule endoscopy (CCE-2) has shown promising accuracy for the diagnosis of overall neoplasia. Advanced neoplasia (AN) represents the main target of colorectal cancer screening programs. Our aim was to assess the diagnostic accuracy of CCE-2 for the detection of AN in patients with a positive result for the fecal immunochemical test (FIT) who are undergoing screening., Methods: Patients aged 50 to 69 years with a positive result for the FIT in 4 population screening programs in Italy and Spain were enrolled. Screenees were asked to undergo CCE-2, followed by traditional colonoscopy (TC). TC was performed the same day or the following morning. Bowel preparation included a split-dose polyethylene glycol-based regimen, with sodium phosphate (NaP) with gastrografin as boosters. The CCE-2 video was read by an endoscopist blinded to the results of TC. The main outcomes were CCE-2 accuracy in terms of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AN when using 2 different size thresholds for TC referral (ie, polyps ≥6 mm and ≥10 mm)., Results: Two hundred twenty-two patients were enrolled, and 178 patients completed both CCE-2 and TC (87.7%). Overall, 59 cases of AN were detected at TC. CCE-2 sensitivity was 90%, specificity was 66.1%, PPV was 57.4%, and NPV was 92.9% for AN when using a 6-mm cut-off (TC referral rate, 52.8%) and 76.7%, 90.7%, 80.7%, and 88.4% when using a 10-mm cut-off (TC referral rate, 32%), respectively. CCE-2 detected that 8 of 9 already developed colorectal cancers. Among the 41 false positives at the 6-mm cut-off, 34 (82.9%) presented with a nonadvanced adenoma at TC. Mean transit time was 4 hours and 4 minutes, and ≥70% of patients excreted the capsule within 5 hours., Conclusions: In an enriched disease setting, we showed the high sensitivity of CCE-2 for the diagnosis of AN at a 6-mm cut-off. The apparently low CCE-2 specificity is related to the choice of AN as the main outcome. (Clinical trial registration number: ISRCTN 62158762.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Endoscopic therapy of benign biliary strictures with multiple plastic stent (MPS) placement has shown satisfactory results. However, the literature describes various benign biliary stricture etiologies. The aim of this study was to evaluate long-term MPS results in patients with postcholecystectomy biliary strictures (PCBSs)., Methods: PCBS patients without complete bile duct transection were included. ERCP consisted of placing an increasing plastic stent number over time, exchanged at regular intervals (3-4 months), until complete morphologic stricture disappearance. After stent removal, patient follow-up comprised liver function tests and clinical assessment., Results: One hundred fifty-four patients (43.5% men; mean age, 53 years) were enrolled; in 43% of the cases, PCBSs were involved or were close to the main hepatic confluence. PCBS resolution rate was 96.7% (n = 149). A mean maximum number of 4.3 ± 1.6 stents were placed side-by-side; a mean of 4.2 ± 1.5 ERCPs per patient was needed to obtain PCBS resolution during a mean treatment period of 11.8 ± 6.4 months. Unscheduled stent exchange because of cholangitis, jaundice, or pain occurred in 7.4% of cases. Procedure-related mortality was absent. Follow-up data were available in 85.2% of cases. After a mean follow-up of 11.1 ± 4.9 years, stricture recurrence rate was 9.4% (n = 12). Subsequent to retreatment, 83.3% of patients (n = 10) were asymptomatic after a mean time of 9 years, whereas 2 patients underwent hepaticojejunostomy because of failed retreatment. Statistical analysis revealed no risk factors for PCBS recurrence after MPS., Conclusions: Endoscopic therapy of PCBSs with MPSs is safe and effective at long-term follow-up. PCBSs involving or close to the main hepatic confluence were successfully treated with MPSs. PCBS recurrence rate is low and can be successful endoscopically retreated without precluding possible surgical treatment., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Preoperative biliary drainage with self-expanding metal stents (SEMSs) brings liver function within an acceptable range in preparation for neoadjuvant therapy (NATx) and provides relief of obstructive symptoms in patients with pancreatic cancer. We compared fully-covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs) for sustained biliary drainage before and during NATx., Methods: Patients with pancreatic cancer and planned NATx who need treatment of jaundice and/or cholestasis before pancreaticoduodenectomy were randomized to FCSEMSs versus UCSEMSs. The primary endpoint was sustained biliary drainage, defined as the absence of reinterventions for biliary obstructive symptoms, and was assessed from SEMS placement until curative intent surgery or at 1 year., Results: The intention-to-treat population included 119 patients (59 FCSEMSs, 60 UCSEMSs). Sustained biliary drainage was equally successful with FCSEMSs and UCSEMSs (72.2% vs 72.9%, noninferiority P = .01). Reasons for FCSEMS and UCSEMS failure differed significantly between the groups and included tumor ingrowth in 0% versus 16.7% (P < .01), and stent migration in 6.8% versus 0% (P = .03), respectively. Serious adverse event rates related to stent placement were not significantly different in both groups (23.7% [14/59] vs 20.0% [12/60], P = .66), as were acute cholecystitis rates when the gallbladder was in situ (9.3% [4/43] vs 4.8% [2/42], P = .68) for FCSEMSs and UCSEMSs, respectively. In our study, independent of stent type, predictors of reinterventions were 4-cm stent length and presence of the gallbladder., Conclusion: FCSEMSs and UCSEMSs provide similar preoperative management of biliary obstruction in patients with pancreatic cancer receiving NATx, but mechanisms of stent dysfunction depend on stent type, stent length, and presence of the gallbladder. (Clinical trial registration number: NCT02238847.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Symptomatic main pancreatic duct (MPD) strictures secondary to chronic pancreatitis (CP) may benefit from endoscopic insertion of single or multiple plastic stents. MPD stricture resolution after single plastic stent removal is uncommon. The use of removable fully covered, self-expandable metal stents (FC-SEMSs) to dilate MPD strictures secondary to CP was evaluated., Methods: Patients with CP and symptomatic MPD stricture located in the head of the pancreas persisting for 3 months or more after placement of a single plastic stent were enrolled in a prospective single-arm trial. A nitinol FC-SEMS was inserted and removed after 6 months. The FC-SEMS diameter and length were chosen according to the stricture anatomy and MPD diameter above the stricture. Our primary objective was FC-SEMS removability. Secondary outcomes were MPD stricture resolution rate and adverse events., Results: Between December 2012 and October 2014, 15 patients (10 male, mean age 60 years) were enrolled. Pancreatic calcifications were present in 6 (40%) patients. Four patients (27%) had a history of alcohol abuse. In 10 patients, the FC-SEMS was inserted through the major papilla, whereas 5 patients (3 pancreas divisum, 2 dominant dorsal duct) received the stent through the minor papilla. One patient developed cholangitis after 24 hours due to occlusion of the biliary sphincterotomy from the FC-SEMS; cholangitis resolved after insertion of a plastic biliary stent. Complete distal migration of the FC-SEMS was reported in 7 patients (47%) (5 asymptomatic, 2 symptomatic with recurrence of pancreatitis). All migrations occurred with the 3-cm-long FC-SEMS. Four patients (27%) developed de novo stricture induced by the FC-SEMS at the level of the flared end and were excluded from the follow-up; 1 patient with FC-SEMS migration had failed stricture resolution. One patient was lost to follow-up. Finally, 9 patients with MPD stricture resolution had a mean follow-up of 38.9 months (range, 5.3-55.3 months), and 89% were asymptomatic., Conclusions: FC-SEMS removability from the MPD in CP was feasible in all cases, and 90% of the patients were asymptomatic after 3 years. Migration seems more frequent with the 3-cm-long FC-SEMS. Occurrence of FC-SEMS-induced pancreatic strictures is a major issue and deserves further assessment. According to our experience, pancreatic FC-SEMSs have promising results, but a careful evaluation in the setting of clinical trials is needed., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer., Methods: Patients with stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemoradiotherapy. LA was performed by using a 300-μm flexible fiber preloaded onto a 22-gauge fine needle. A 1064-nm wavelength neodymium-yttrium aluminum garnet (Nd:YAG) laser light with different power settings of 2 W for 800 J, 1000 J, and 1200 J; 3 W for 800 J, 1000 J, and 1200 J; and 4 W for 800 J, 1000 J, and 1200 J was used. Each patient was treated with a single application of 1 of these settings. The application time of the power settings ranged from 200 to 600 seconds., Results: Nine patients (median age, 74.7; range 55-85) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range, 21-45). The ablation area, demonstrated by 24-hour CT, ranged from .4 cm 3 (for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm 3 (for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events., Conclusion: In our human experience, EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Numerous randomized studies have shown that changing certain features of colonoscopes, usually incorporated when switching from one endoscope generation to the next, mostly do not increase adenoma yield. There is, however, indirect evidence that it may be necessary to skip one instrument generation (ie, changing from one generation to the next but one) to achieve this effect., Methods: We compared the latest-generation colonoscopes from one company (Olympus Exera III, 190-C) with the next to last one (Olympus 160/5-C) in a prospective multicenter study randomized for the order of colonoscopes in a tandem fashion, involving 2 different examiners. Patients with increased risk for colorectal neoplasia undergoing colonoscopy (positive fecal occult blood test, personal/familial history of colorectal cancer/adenoma, rectal bleeding, recent change in bowel movements) were included. The primary outcome was the adenoma miss rate with the 190 (190-C) colonoscope in comparison with the 160/5 colonoscope (160/5-C)., Results: A total of 856 patients (48.8% male; mean age, 58.3 years) with a personal (41%) or family (38%) history of colorectal neoplasia, rectal bleeding (19%), and other indications were included. Of the 429 patients in the 190-C first group, 16.6% (95% confidence interval [CI], 13.0%-20.1%) had at least one adenoma missed during the first procedure, compared with 30.2% (95% CI, 25.9%-34.6%) in the group with 160/5-C first (P < .001). Similarly, the adenoma detection rate during the first colonoscopy was 43.8% versus 36.5% (P = .030) for 190-C versus 160/5-C, respectively., Conclusions: This randomized tandem trial showed lower adenoma miss rates and higher adenoma detection rates for the newer 190 colonoscopes compared with the 160/5 series. These results suggest that it takes multiple improvements, such as those implemented over 2 instrument generations, before an effect on adenoma (miss) rate can be observed. (Study registration number: ISRCTN 2010-A01256-33.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Flexible endoscopy septotomy for Zenker's diverticulum (ZD) is an alternative to endostapling; however, long-term data are sparse and studies are heterogeneous. The aim of this study was to assess the clinical success of flexible endoscopy diverticuloscope-assisted septotomy according to all ZD-related symptoms and to identify potential prognostic variables., Methods: A prospective database of all patients with ZD undergoing septotomy and followed up for 24 months or longer was analyzed. Septotomy was conducted by using a diverticuloscope-assisted technique. Dysphagia, regurgitation, and respiratory symptoms (during the day and at night) were scored by their weekly frequency from 0 to 3 when on a solid food diet. Clinical success (asymptomatic state) was defined as a maximum of 2 symptoms with a score of 1 (once per week). Prognostic variables of clinical success included age, sex, pretreatment total symptom score, pre- and posttreatment ZD size, and septotomy length. The Kaplan-Meier method and Cox proportional hazards model were used to calculate the crude and adjusted hazard ratio (HR)., Results: Septotomy was attempted and achieved in a single session in 89 patients. Clinical success at the intention-to-treat analysis was 69%, 64%, and 46% at 6, 24, and 48 months, respectively. Adverse events occurred in 3 patients: perforation in 2 (2%) and postprocedural bleeding in 1 (1%). Independent variables for failure at 6 months were a septotomy length ≤25 mm (HR 6.34) and pretreatment ZD size ≥50 mm (HR 11.08), whereas at 48 months, they were septotomy length ≤25 (HR 2.20) and posttreatment ZD size ≥10 mm (HR 2.03). Success rates for ZD ranging in size from 30 mm to 49 mm with a septotomy >25 mm were 100% and 71% at 6 months and 48 months, respectively., Conclusion: Flexible endoscopic septotomy for ZD is feasible and safe. Treatment success correlates with the length of the septotomy and the size of ZD, which should ultimately determine the appropriate approach., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic resection of superficial neoplasms in inflammatory bowel disease (IBD) is appropriate if a complete resection can be achieved. However, EMR is ineffective for large, nonpolypoid neoplasms in IBD due to submucosal fibrosis, and no data are available on the efficacy of endoscopic submucosal dissection (ESD)., Objective: To assess ESD feasibility and efficacy for large, nonpolypoid neoplasms in patients with IBD., Design: Prospective case series., Setting: Multicenter: Italian and Japanese centers., Patients: Consecutive patients with long-standing ulcerative colitis and a superficial nonpolypoid neoplasm, >20 mm within the colitic mucosa., Intervention: Neoplasm characterization and delineation by chromoscopy and narrow-band imaging. ESD performed according to the standard technique., Main Outcome Measurements: Feasibility, safety, curative resection rates., Results: Nine patients with 10 neoplasms were included (7 and 3 in the Italian and Japanese centers, respectively). Neoplasms were laterally spreading tumors-non-granular in 5 cases, in the left side of the colon in 7, had median size of 33 mm, and were associated with scar in 5 cases. Margin delineation was difficult in 5 cases. Submucosal fibrosis was present in 9 cases. ESD was en bloc with negative margins (R0) in 8 cases, and curative in 7. No endoscopic invisible dysplasia or cancer was found during the follow-up (median 24 months, range 6-72 months) at the resection site and elsewhere within the colitic mucosa., Limitations: Small series., Conclusion: ESD achieves curative resections in patients with IBD, but the procedure is difficult because of the high prevalence of submucosal fibrosis. Patients need to be accurately evaluated before resection and adhere to strict long-term follow-ups., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study., Objective: To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures., Design: Prospective, international, multicenter study., Setting: Six academic centers., Patients: A total of 136 patients with indeterminate biliary strictures., Interventions: Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months., Main Outcome Measurements: Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling., Results: A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy., Limitations: No randomization of care maps. pCLE not blinded., Conclusion: pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. (, Clinical Trial Registration Number: NCT01392274.)., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Malignant gastric outlet obstruction is often treated by stent placement., Objective: To investigate the outcomes of stent placement in the palliative treatment of malignant neoplasms., Design: Prospective, observational, multicenter registry., Setting: Six tertiary care centers in 5 countries., Patients: A total of 108 adult patients with malignant gastric outlet obstruction., Interventions: Placement of an uncovered, self-expandable, metal duodenal stent., Main Outcome Measurements: The primary endpoint was stent patency at 14 days after stent implantation. Secondary endpoints included stent patency at 1, 2, 3, and 6 months, gastric outlet obstruction scoring system (GOOSS) scores at 14 days and 1, 2, 3, and 6 months after stent deployment, technical success, adverse events, and patient survival (ie, confirmed duration of the implant)., Results: Technical success was achieved in 99.1% of stent placements. Stent patency at 14 days was 94.6%. Kaplan-Meier estimates of stent patency were 92.9% at 1 month, 86.2% at 2 months, 81.9% at 3 months, and 63.4% at 6 months. At 14 days, GOOSS scores increased by a median of 1 point. The overall GI adverse event rate was 32.4%; however, the stent-related adverse event rate was 19.4%. The median implant duration was 47 days (range 0-195 days)., Limitations: Observational study, no control group., Conclusions: Duodenal stent placement resulted in prompt relief of malignant gastric outlet obstruction and improved GOOSS scores. (, Clinical Trial Registration Number: NCT00991614.)., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Laser ablation (LA) with a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser is a minimally invasive approach able to achieve a high rate of complete tissue necrosis. In a previous study we described the feasibility of EUS-guided Nd:YAG pancreas LA performed in vivo in a porcine model., Objective: To establish the best laser setting of Nd:YAG lasers for pancreatic tissue ablation. A secondary aim was to investigate the prediction capability of a mathematical model on ablation volume., Design: Ex vivo animal study., Setting: Hospital animal laboratory., Subjects: Explanted pancreatic glands from 60 healthy farm pigs., Intervention: Laser output powers (OP) of 1.5, 3, 6, 10, 15, and 20 W were supplied. Ten trials for each OP were performed under US guidance on ex vivo healthy porcine pancreatic tissue., Main Outcome Measurements: Ablation volume (Va) and central carbonization volume (Vc) were measured on histologic specimens as the sum of the lesion areas multiplied by the thickness of each slide. The theoretical model of the laser-tissue interaction was based on the Pennes equation., Results: A circumscribed ablation zone was observed in all histologic specimens. Va values grow with the increase of the OP up to 10 W and reach a plateau between 10 and 20 W. The trend of Vc values rises constantly until 20 W. The theoretical model shows a good agreement with experimental Va and Vc for OP between 1.5 and 10 W., Limitations: Ex vivo study., Conclusion: Volumes recorded suggest that the best laser OP could be the lowest one to obtain similar Va with smaller Vc in order to avoid the risk of thermal injury to the surrounding tissue. The good agreement between the two models demonstrates the prediction capability of the theoretical model on laser-induced ablation volume in an ex vivo animal model and supports its potential use for estimating the ablation size at different laser OPs., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Differential diagnosis of pancreatic solid masses with EUS-guided FNA (EUS-FNA) is still challenging in about 15% of cases. Mutation of the K-ras gene is present in over 75% of pancreatic adenocarcinomas (PADC)., Objective: To assess the accuracy of K-ras gene mutation analysis for diagnosing PADC., Design: We systematically searched the electronic databases for relevant studies published. Data from selected studies underwent meta-analysis by use of a bivariate model providing a pooled value for sensitivity, specificity, diagnostic odds ratio, and summary receiver operating characteristic curve., Setting: Meta-analysis of 8 prospective studies., Patients: Total of 931 patients undergoing EUS-FNA for diagnosis of pancreatic solid masses., Intervention: K-ras mutation analysis., Main Outcome Measurements: Diagnostic accuracy of K-ras mutation analysis and of combined diagnostic strategy by using EUS-FNA and K-ras mutation analysis in the diagnosis of PADC., Results: The pooled sensitivity of EUS-FNA for the differential diagnosis of PADC was 80.6%, and the specificity was 97%. Estimated sensitivity and specificity were 76.8% and 93.3% for K-ras gene analysis, respectively, and 88.7% and 92% for combined EUS-FNA plus K-ras mutation analysis. Overall, K-ras mutation testing applied to cases that were inconclusive by EUS-FNA reduced the false-negative rate by 55.6%, with a false-positive rate of 10.7%. Not repeating EUS-FNA in cases in which mutation testing of the K-ras gene is inconclusive would reduce the repeat-biopsy rate from 12.5% to 6.8%., Limitations: Small number of studies and between-study heterogeneity., Conclusion: K-ras mutation analysis can be useful in the diagnostic work-up of pancreatic masses, in particular when tissue obtained by EUS-FNA is insufficient, and the diagnosis inconclusive., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic submucosal dissection (ESD) has revolutionized the resection of GI superficial neoplasms, but adoption in Western countries is significantly delayed., Objective: To evaluate a stepwise colorectal endoscopic submucosal dissection (ESD) learning and operative training protocol., Design: Prospective study in the Western setting., Setting: This study took place in a nonacademic hospital with one endoscopist expert in therapeutic endoscopy but novice in ESD., Patients: Indications for ESD were superficial neoplasms 20 mm and larger without ulcerations or fibrosis., Intervention: Training consisted of 5 unsupervised ESDs on isolated stomach, an observation period at an ESD expert Japanese center, 1 supervised ESD on isolated stomach, and retraining on 1 rectal ESD under supervision. The operative training on patients was performed without supervision moving from the rectum to the colon according to the competence achieved., Main Outcome Measurements: Competence was defined as an 80% en bloc resection rate plus a statistically significant reduction in operating time per square centimeter. Learning curves were calculated based on consecutive blocks of 5 procedures., Results: From February 2009 to February 2012, 30 rectal and 30 colonic ESDs were performed. The rectal ESD learning curve showed that the en bloc resection rate was 80% after 5 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P = .0079); perforation occurred in 1 patient. The colonic ESD learning curve showed that the en bloc resection rate was 80% after 20 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P = .031); perforations occurred in 2 patients., Limitations: Single-center design., Conclusions: A minimal intensive training seems sufficient for endoscopists expert in therapeutic procedures to take up ESD in a not overly arduous incremental method with separate and sequential learning curves for the rectum and colon., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Preoperative determination of Ki-67 expression, an important prognostic factor for grading nonfunctioning pancreatic endocrine tumors (NF-PETs), remains an important clinical challenge., Objective: To prospectively evaluate the feasibility, yield, and clinical impact of EUS-guided fine-needle tissue acquisition (EUS-FNTA) with a large-gauge needle to obtain tissue samples for histologic diagnosis and Ki-67 analysis in patients with suspected NF-PETs., Design: Prospective cohort study., Setting: Tertiary-care academic medical center., Patients: Consecutive patients with a single pancreatic lesion suspicious for NF-PET on imaging., Intervention: EUS-FNTA with a 19-gauge needle., Main Outcome Measurements: Feasibility and yield of EUS-FNTA for diagnosis and Ki-67 expression determination., Results: Thirty patients (mean [± SD] age 55.7 ± 14.9 years), with a mean (± SD) lesion size of 16.9 ± 6.1 mm were enrolled. EUS-FNTA was successfully performed without complications in all patients, with a mean (± SD) of 2.7 ± 0.5 passes per patient. Adequate samples for histologic examination were obtained in 28 of the 30 patients (93.3%). Ki-67 determination could be performed in 26 of these 28 patients (92.9%, 86.6% overall), 12 of whom underwent surgical resection. Preoperative and postoperative Ki-67 proliferation indexes were concordant in 10 patients (83.3%), whereas 2 patients were upstaged from G1 to G2 or downstaged from G2 to G1, respectively., Limitations: Single center study with a single operator., Conclusion: In patients with suspected nonfunctioning low-grade to intermediate-grade pancreatic neuroendocrine tumors (p-NETs), retrieval of tissue specimens with EUS-FNTA by using a 19-gauge needle is safe, feasible, and highly accurate for both diagnosis and Ki-67 determination. A Ki-67 proliferative index acquired through this technique might be of great help for further therapeutic decisions., (Copyright © 2012. Published by Mosby, Inc.)

Background: Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate., Objective: To evaluate the safety and efficacy of TOGA at 12-month follow-up., Design: Prospective, multicenter, single-arm trial., Setting: Two tertiary-care referral medical centers., Patients: This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40)., Intervention: The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals., Main Outcome Measurements: Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use., Results: Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively., Limitations: Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up., Conclusion: The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: EUS-guided drainage of pancreatic fluid collections (PFCs) is commonly performed with oblique-viewing echoendoscopes. However, accessing the PFC under an oblique angle can make drainage difficult. These difficulties might be overcome by using a forward-viewing echoendoscope., Objective: To compare endoscopic PFC drainage with an oblique-viewing versus a forward-viewing echoendoscope with emphasis on ease of endoscopic drainage., Design: Multicenter, randomized, controlled trial., Setting: Four tertiary-care referral centers., Patients: This study involved 58 patients with PFCs., Intervention: Patients with PFCs (≥ 6 cm) in whom drainage was indicated were randomized to receive EUS-guided drainage with a forward-viewing echoendoscope or an oblique-viewing echoendoscope. In cases of failed drainage, patients were crossed over to the other study arm., Main Outcome Measurements: Ease of EUS-guided drainage measured by procedure time. Secondary endpoints included technical success, EUS endoscope preference, clinical success, and adverse events., Results: Fifty-eight consecutive patients underwent randomization, of whom 52 were available for primary endpoint analysis. All 26 EUS-guided procedures done with the oblique-viewing echoendoscope and 24 of the 26 procedures done with the forward-viewing echoendoscope were technically successful. Mean (± standard deviation) procedure time was 24:55 ± 9:58 minutes in the forward-viewing echoendoscope group and 27:04 ± 9:58 minutes in the oblique-viewing echoendoscope group (P = .44). Median overall procedure ease was graded as equal (easy) in both groups. Drainage-related adverse events occurred in 2 patients (8%) in the forward-viewing echoendoscope group versus none in the oblique-viewing echoendoscope group (P = .56). Overall clinical success was achieved in 82% of patients (95% confidence interval, 69%-91%)., Limitations: Derived main outcome parameter and highly specialized endoscopists in tertiary-care referral centers., Conclusion: This multicenter, randomized, controlled trial comparing the performance of oblique-viewing echoendoscopes and forward-viewing echoendoscopes in draining PFCs did not show a difference in ease of EUS-guided drainage or procedure safety and efficacy between the forward-viewing echoendoscope and the oblique-viewing echoendoscope. Clinical success was achieved in 82% of patients., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported., Objective: To confirm the utility of SOC in more widespread clinical use., Design: Prospective clinical cohort study., Setting: Fifteen endoscopy referral centers in the United States and Europe., Patients: Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy., Interventions: SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy., Main Outcome Measurements: Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal., Results: The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy., Limitations: The study was observational in design with no control group., Conclusions: Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: The ability to obtain tissue samples for histological examination during EUS has theoretical advantages over cytology alone., Objective: To prospectively evaluate the feasibility and yield of EUS-guided fine-needle tissue acquisition (EUS-FNTA) with a large-gauge needle in patients in whom we expected histology to be more useful than cytology to reach a definitive diagnosis., Design: Prospective cohort study., Setting: Tertiary care academic medical center., Patients: Consecutive patients with subepithelial lesions, esophagogastric wall thickening, mediastinal and abdominal masses/lymphadenopathy of unknown origin, or pancreatic lesions after nondiagnostic FNA., Interventions: EUS-FNTA with a 19-gauge needle., Main Outcome Measurements: Feasibility and yield of EUS-FNTA., Results: A total of 120 patients with a mean age of 61 ± 14.6 years and mean lesion size of 38 ± 25 mm (range 8-140 mm) were enrolled. FNTA was successfully performed in all but 1 patient (98.9%), and adequate samples for histological examination were obtained in 116 of the 119 patients (97.5%) in whom EUS-FNTA was technically successful. A mean of 2.8 ± 0.8 passes per patient were performed. At the time of current follow-up, a definitive diagnosis was available in 117 of the 120 patients (97.5%), with only 8 false-negative results. The sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy of EUS-FNTA in the 117 patients with a definitive diagnosis were 91.8%, 100%, 100%, 71.4%, and 93.2%, respectively., Limitations: Single-center study with limited power., Conclusions: EUS-FNTA by using a large-gauge needle has a high yield and promising diagnostic accuracy and could be used when histology may be more useful than cytology to reach a definitive diagnosis., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system., Objective: To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy., Design and Setting: Prospective, multicenter trial including 8 European sites., Patients: This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed., Intervention: CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day., Main Outcome Measurements: CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed., Results: Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients., Limitations: Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients., Conclusion: In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

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 © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic dilation of postoperative biliary strictures with increasing numbers of stents was first described by our group in 2001 with promising results after a long-term follow-up (mean 4 years)., Objective: To verify results of endoscopic treatment of postoperative biliary strictures at a very-long-term follow-up., Design: Single center, follow-up study., Setting: Tertiary-care, academic referral center., Patients: A group of 42 patients from our 2001 study, who had undergone endoscopic dilation of postoperative biliary strictures with the multiple endoscopic stenting technique, underwent systematic follow-up. The last telephone follow-up was done in September 2009., Intervention: Clinical conditions and the occurrence of new biliary symptoms during the follow-up period were assessed, and results of the most recent liver function tests and abdominal US were recovered., Main Outcome Measurements: Occurrence of cholangitis and liver function test evaluation during the follow-up period., Results: Of the 40 patients who were alive at the end of the study published in 2001, 5 (12.5%) died of unrelated causes after a mean of 6.7 years (range 3-13.3 years) from the end of treatment, without further biliary symptoms. The overall mean follow-up time for the remaining 35 patients (87.5%) was 13.7 years (range 11.7-19.8 years). Seven patients (20%) experienced recurrent acute cholangitis after a mean of 6.8 years (range 3.1-11.7 years) from the end of treatment. All 7 of these patients underwent ERCP. Four of the 7 patients had postoperative biliary stricture recurrence (n = 4/35, 11.4%) that was retreated endoscopically with placement of stents, and the other 3 patients had common bile duct stones (n = 3/35, 8.6%) that were extracted. No stricture or bile duct stone recurrences after retreatment were recorded after a mean follow-up period of a further 7.1 years (range 2.5-12.1 years). Twenty-eight patients remained asymptomatic with normal liver function test results and abdominal US results after a mean follow-up period of 13.7 years (range 11.7-19.8 years)., Limitations: Telephone follow-up., Conclusion: Results of multiple endoscopic stenting for postoperative biliary strictures remain excellent even after a very-long-term follow-up. The stricture recurrence rate is low, and recurrences can be retreated endoscopically., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy., Objective: To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement., Design: Prospective, multicenter cohort study., Setting: Four referral centers., Patients: The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients., Intervention: Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent., Main Outcome Measurements: Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent., Results: Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration)., Limitations: Small sample size, lack of a control group., Conclusion: Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Laser ablation with a neodymium:yttrium aluminum garnet (Nd:YAG) laser can achieve a high rate of complete tissue necrosis and has been applied as a minimally invasive, palliative option in hepatocellular carcinoma, liver metastasis in colorectal cancer, and malignant thyroid nodules., Objective: To assess the in vivo feasibility of EUS-guided laser ablation with an Nd:YAG laser of normal pancreatic tissue of a porcine model., Design: Prospective investigation., Setting: Hospital animal laboratory., Subjects: Eight pigs., Interventions: EUS-guided puncture of the pancreatic tail with a laser-beam fiber. An Nd:YAG laser (1.064 nm) was used, with an output power of 2 and 3 W and a total delivered energy of 500 and 1000 J in continuous mode., Main Outcome Measurements: The 24-hour follow-up of the pigs was focused on clinical and laboratory aspects. Results of histological studies of the pancreas were obtained 24 hours after the procedure on necroscopy tissue., Results: There were no technical limitations to the performance of the procedure. Tissue necrosis, localized in the pancreatic parenchyma, was observed in all animals on histological examination. The volume of ablation tissue ranged from a mean of 314 mm(3) to 483 mm(3). The ablation area ranged from a mean of 49 mm(2) to 80 mm(2). No major postprocedure complications were recorded, and all the pigs survived at 24 hours., Limitation: Animal study., Conclusions: EUS-guided laser ablation of the pancreas with an Nd:YAG laser is feasible in a porcine model., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)