AGA Clinical Practice Update on Endoscopic Full-Thickness Resection for the Management of Gastrointestinal Subepithelial Lesions: Commentary.

DESCRIPTION: Subepithelial lesions of the gastrointestinal tract are not encountered uncommonly during routine endoscopy. There has been remarkable progress in the development of endoscopic options for the resection of subepithelial lesions, including full-thickness resection. The purpose of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to describe the various techniques for endoscopic full-thickness resection and to facilitate their appropriate application in the management of subepithelial lesions. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.

Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study.

BACKGROUND AND AIMS: EUS-guided liver biopsy (EUS-LB) sampling is being increasingly used. We performed a prospective randomized trial to compare specimen adequacy of a 19-gauge fine-needle biopsy (FNB) needle with a 22-gauge FNB Franseen tip needle for EUS-LB sampling. METHODS: Forty-two consecutive patients referred for EUS-LB sampling were prospectively randomized to a 19-gauge or 22-gauge FNB needle. When the specimen with the 22-gauge needle was macroscopically inadequate, an additional pass with the 19-gauge needle was done. Bilobar EUS-LB sampling was performed with heparinized wet suction using 1 pass and 3 actuations per lobe. Descriptive statistics were computed for all variables. RESULTS: Biopsy sampling was performed for abnormal liver enzymes in 95.5% of patients (57% women; average age, 51 years). Five patients undergoing sampling with the 22-gauge FNB needle had macroscopically inadequate specimens and required additional biopsy sampling with the 19-gauge FNB needle. Mean preprocessing length of the longest tissue core was 21.5 ± 6.3 mm with a 19-gauge FNB needle compared with 9.4 ± 5.5 mm with the 22-gauge FNB needle (P < .001). Postprocessing specimens were significantly longer with 19-gauge than with 22-gauge FNB needles (17.4 mm vs 6.8, P < .001). There were no adverse events, and postprocedure pain and discomfort was similar in both groups (14% for 19-gauge vs 10% for 22-gauge, P = .99). CONCLUSIONS: Liver core biopsy sampling using the 19-gauge FNB needle is superior to the 22-gauge FNB needle in terms of length of longest core and aggregate specimen length. Considerably more fragmentation of the 22-gauge cores occurs during tissue processing. No increased postprocedure pain or AEs were found with the 19-gauge needle. A 19-gauge FNB needle is preferred to the 22-gauge FNB needle for EUS-LB. (Clinical trial registration number: NCT04806607.).

Effects of Glucagon-like Peptide-1 Receptor Agonists on Upper Endoscopy in Diabetic and Non-Diabetic Patients.

BACKGROUND AND AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) promote weight loss by suppressing appetite, enhancing satiety, regulating glucose metabolism and delaying gastric motility. We sought to determine whether GLP-1 RA use could impact sedated medical procedures like esophagogastroduodenoscopy (EGD). METHODS: We conducted a retrospective study on 35,183 patients who underwent EGD between 2019 and 2023, 922 of which were using a GLP-1-RA. Data were collected regarding demographics, diabetes status, retained gastric contents during EGD (RGC), incidence of aborted EGD, and necessity for repeat EGD. RESULTS: GLP-1 RA use was associated with a fourfold increase in the retention of gastric contents (p<0.0001), fourfold higher rates of aborted EGD (p<0.0001), and twice the likelihood of requiring repeat EGD (p=0.0001), even after stratifying for presence of diabetes. CONCLUSIONS: GLP-1 RA use can lead to delayed gastric emptying, affecting EGD adequacy regardless of the presence of diabetes, and may warrant dose adjustment to improve safety and efficacy of these procedures.

The Tissue Systems Pathology Test Objectively Risk-Stratifies Patients With Barrett's Esophagus: Results From a Multicenter US Clinical Experience Study.

BACKGROUND: Barrett's esophagus (BE) is a diagnosis of esophageal intestinal metaplasia, which can progress to esophageal adenocarcinoma (EAC), and guidelines recommend endoscopic surveillance for early detection and treatment of EAC. However, current practices have limited effectiveness in risk-stratifying patients with BE. AIM: This study aimed to evaluate use of the TSP-9 test in risk-stratifying clinically relevant subsets of patients with BE in clinical practice. METHODS: TSP-9 results for tests ordered by 891 physicians for 8080 patients with BE with clinicopathologic data were evaluated. Orders were from nonacademic (94.3%) and academic (5.7%) settings for nondysplastic BE (NDBE; n=7586; 93.9%), indefinite for dysplasia (IND, n=312, 3.9%), and low-grade dysplasia (LGD, n=182, 2.3%). RESULTS: The TSP-9 test scored 83.2% of patients with low risk, 10.6% intermediate risk, and 6.2% high risk, respectively, for progression to HGD/EAC within 5 years. TSP-9 provided significant risk-stratification independently of clinicopathologic features, within NDBE, IND, and LGD subsets, male and female, and short- and long-segment subsets of patients. TSP-9 identified 15.3% of patients with NDBE as intermediate/high-risk for progression, which was 6.4 times more than patients with a pathology diagnosis of LGD. Patients with NDBE who scored intermediate or high risk had a predicted 5-year progression risk of 8.1% and 15.3%, respectively, which are similar to and higher than published progression rates in patients with BE with confirmed LGD. CONCLUSIONS: The TSP-9 test identified a high-risk subset of patients with NDBE who were predicted to progress at a higher rate than confirmed LGD, enabling early detection of patients requiring management escalation to reduce the incidence of EAC. TSP-9 scored the majority of patients with NDBE as low risk, providing support to adhere to 3- to 5-year surveillance per guidelines.

A Delphi Method for Development of a Barrett's Esophagus Question Prompt List as a Communication Tool for Optimal Patient-physician Communication.

BACKGROUND METHODS: The question prompt list content was derived through a modified Delphi process consisting of 3 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of Barrett's esophagus" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" Questions were reviewed and categorized into themes. In round 2, experts rated questions on a 5-point Likert scale. In round 3, experts rerated questions modified or reduced after the previous rounds. Only questions rated as "essential" or "important" were included in Barrett's esophagus question prompt list (BE-QPL). To improve usability, questions were reduced to minimize redundancy and simplified to use language at an eighth-grade level (Fig. 1). RESULTS: Twenty-one esophageal medical and surgical experts participated in both rounds (91% males; median age 52 years). The expert panel comprised of 33% esophagologists, 24% foregut surgeons, and 24% advanced endoscopists, with a median of 15 years in clinical practice. Most (81%), worked in an academic tertiary referral hospital. In this 3-round Delphi technique, 220 questions were proposed in round 1, 122 (55.5%) were accepted into the BE-QPL and reduced down to 76 questions (round 2), and 67 questions (round 3). These 67 questions reached a Flesch Reading Ease of 68.8, interpreted as easily understood by 13 to 15 years olds. CONCLUSIONS: With multidisciplinary input, we have developed a physician-derived BE-QPL to optimize patient-physician communication. Future directions will seek patient feedback to distill the questions further to a smaller number and then assess their usability.

Safety and efficacy of EsoFLIP dilation in patients with esophageal dysmotility: a systematic review.

Esophageal manometry is utilized for the evaluation and classification of esophageal motility disorders. EndoFlip has been introduced as an adjunctive test to evaluate esophagogastric junction (EGJ) distensibility. Treatment options for achalasia and EGJ outflow obstruction (EGJOO) include pneumatic dilation, myotomy, and botulinum toxin. Recently, a therapeutic 30 mm hydrostatic balloon dilator (EsoFLIP, Medtronic, Minneapolis, MN, USA) has been introduced, which uses impedance planimetry technology like EndoFlip. We performed a systematic review to evaluate the safety and efficacy of EsoFLIP in the management of esophageal motility disorders. A systematic literature search was performed with Medline, Embase, Web of science, and Cochrane library databases from inception to November 2022 to identify studies utilizing EsoFLIP for management of esophageal motility disorders. Our primary outcome was clinical success, and secondary outcomes were adverse events. Eight observational studies including 222 patients met inclusion criteria. Diagnoses included achalasia (158), EGJOO (48), post-reflux surgery dysphagia (8), and achalasia-like disorder (8). All studies used 30 mm maximum balloon dilation except one which used 25 mm. The clinical success rate was 68.7%. Follow-up duration ranged from 1 week to a mean of 5.7 months. Perforation or tear occurred in four patients. EsoFLIP is a new therapeutic option for the management of achalasia and EGJOO and appears to be effective and safe. Future comparative studies with other therapeutic modalities are needed to understand its role in the management of esophageal motility disorders.

Low adenoma burden in unselected patients with a pathogenic APC variant.

PURPOSE: Genomic screening can improve clinical outcomes, but presentation of individuals with risk for polyposis identified via genomic screening is unknown. To inform assessment of clinical utility of genomic screening for polyposis risk, clinical presentation of individuals in an unselected health care system cohort with an APC pathogenic or likely pathogenic (P/LP) variant causative of familial adenomatous polyposis are described. METHODS: Electronic health records of individuals with an APC P/LP variant identified via the MyCode program (MyCode APC+) were reviewed to assess adenoma burden and compare it among individuals with a clinical diagnosis of familial adenomatous polyposis and matched variant-negative controls. RESULTS: The prevalence of APC P/LP variants in this health care cohort is estimated to be 1 in 2800. Twenty-four MyCode APC+ individuals were identified during the study period. Median age at result disclosure was 53 years. Rate of clinical polyposis was 8%. Two of six participants with a classic region variant and none of those with an attenuated region variant had polyposis. MyCode APC+ participants did not differ from controls in cumulative adenoma count. CONCLUSION: APC P/LP variant prevalence estimate in the MyCode cohort is higher than prior published prevalence rates. Individuals with APC P/LP variants identified via genomic screening had a low adenoma burden.

Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.

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.).

Clinical and financial outcomes of per-oral endoscopic myotomy compared to laparoscopic heller myotomy for treatment of achalasia.

BACKGROUND: Previous studies analyzing short-term outcomes for per-oral endoscopic myotomy (POEM) have shown excellent clinical response rates and shorter operative times compared to laparoscopic Heller myotomy (LHM). Despite this, many payors have been slow to recognize POEM as a valid treatment option. Furthermore, comparative studies analyzing long-term outcomes are limited. This study compares perioperative and long-term outcomes, cost-effectiveness, and reimbursement for POEM and LHM at a single institution. METHODS: Adult patients who underwent POEM or LHM between 2014 and 2021 and had complete preoperative data with at least one complete follow up, were retrospectively analyzed. Demographic data, success rate, operative time, myotomy length, length of stay, pre- and postoperative symptom scores, anti-reflux medication use, cost and reimbursement were compared. RESULTS: 58 patients met inclusion with 25 undergoing LHM and 33 undergoing POEM. There were no significant differences in preoperative characteristics. Treatment success (Eckardt ≤ 3) for POEM and LHM was achieved by 88% and 76% of patients, respectively (p = 0.302). POEM patients had a shorter median operative time (106 min. vs. 145 min., p = 0.003) and longer median myotomy length (11 cm vs. 8 cm, p < 0.001). All LHM patients had a length of stay (LOS) ≥ 1 day vs. 51.5% for POEM patients (p < 0.001). Both groups showed improvements in dysphagia, heartburn, regurgitation, Eckardt score, GERD HRQL, RSI, and anti-reflux medication use. The improvement in dysphagia score was greater in patients undergoing POEM (2.30 vs 1.12, p = 0.003). Median hospital reimbursement was dramatically less for POEM ($3,658 vs. $14,152, p = 0.002), despite median hospital costs being significantly lower compared to LHM ($2,420 vs. $3,132, p = 0.029). RESULTS: POEM is associated with a shorter operative time and LOS, longer myotomy length, and greater resolution of dysphagia compared to LHM. POEM costs are significantly less than LHM but is poorly reimbursed.

Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication.

BACKGROUND: Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF). METHODS: This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett's esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching. RESULTS: Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events. CONCLUSION: Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.

Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) is an effective treatment for surgical failures or non-operative patients.

BACKGROUND: Symptomatic Zenker's diverticulum (ZD) occurs mostly in the elderly, who often have significant comorbidities, and poor neck hyperextension, putting them at high risk for surgical management while also increasing the potential of technical failure. Flexible endoscopic incisional therapy for Zenker's diverticulum (FEIT-Z) offers a safe approach to this problem with high technical and clinical success rates. There are limited data on its use following a failed surgical approach or in patients unfit for a surgical approach. The aim of this study was to assess clinical and technical outcomes of FEIT-Z in patients who were non-operative candidates or refused or failed surgical management. METHODS: Patients who underwent FEIT-Z from January 2015 to February 2019 at a tertiary referral center were included. Patient demographics, prior ZD surgical history, procedural data, dysphagia scores, clinical success, and adverse events (AE) were collected. Univariable analysis was performed to assess differences between pre- and post-FEIT-Z dysphagia scores. RESULTS: 30 patients undergoing FEIT-Z were included. Seven had a prior failed ZD surgical approach, 6 refused surgical management, and 17 were deemed to be non-operative candidates based on medical comorbidities. Mean age was 78.4 (± 12.1) and 36.7% were male. Technical success of FEIT-Z was 96.7%. There was a significant improvement in dysphagia scores after FEIT-Z: 2.3 (± 0.64) vs. before, 0.4 (± 0.76) (p < 0.001). Long-term clinical success was achieved in 73.3% of patients. Adverse events were seen in 23.3% of patients; however, these were graded as mild in 85.7% of patients. One microperforation was managed with antibiotics. CONCLUSION: FEIT-Z is a safe procedure with low adverse events and a high rate of technical and clinical success. FEIT-Z can be done in patients who fail previous surgical treatment, refuse a surgical approach, or are not surgical candidates due to medical comorbidity or other factors.

Single-pass 1-needle actuation versus single-pass 3-needle actuation technique for EUS-guided liver biopsy sampling: a randomized prospective trial (with video).

BACKGROUND AND AIMS: Several reports have validated EUS-guided liver biopsy sampling (EUS-LB) as safe and effective. Nineteen-gauge EUS aspiration (FNA) or core (fine-needle biopsy [FNB]) needles are used, but different needle techniques can yield variable outcomes. Some data show that 1 pass (single liver puncture) with 1 actuation (1 to-and-fro needle movement) may be enough to obtain a satisfactory specimen. However, there has not been a head-to-head comparison of single versus multiple needle actuations for EUS-LB. METHODS: This was a prospective randomized trial of EUS-LB in 40 patients comparing tissue yields and adequacy using 1 pass, 1 actuation (1:1) versus 1 pass 3 actuations (1:3) of an FNB needle. The primary outcome was number of complete portal triads (CPTs). Secondary outcomes were length of the longest piece, aggregate specimen length, number of cores >9 mm, and adverse events (AEs). Computerized randomization determined selection (either 1:1 or 1:3 with fanning technique). Sample lengths were measured before pathologic processing. RESULTS: Both groups had similar demographics and indications for EUS-LB. All biopsy samples were adequate for pathologic interpretation. Compared with 1:1, biopsy sampling with 1:3 yielded more CPTs (mean [standard deviation], 17.25 [6.2] vs 24.5 [9.88]; P < .008) and longer aggregate specimen length (6.89 cm [1.86] vs 12.85 cm [4.02]; P < .001). AEs were not statistically different between the techniques. No severe AEs were noted. CONCLUSIONS: EUS-LB using the 1:3 technique produced longer liver cores with more CPTs than the 1:1 technique with an equivalent safety profile. Two needle passes are more likely to provide tissue adequacy according to the American Association for the Study of Liver Diseases guidelines. (Clinical trial registration number: UMIN 000040101.).

Safety and efficacy of a novel powered endoscopic debridement tissue resection device for management of difficult colon and foregut lesions: first multicenter U.S. experience.

BACKGROUND AND AIMS: The EndoRotor, nonthermal, powered endoscopic debridement (PED) instrument (Interscope Inc, Whitinsville, Mass, USA), is a novel device used in the GI tract. It uses adjustable suction and a rotary cutting blade to precisely resect mucosal and submucosal tissue. Our aim was to assess the technical feasibility, safety, and efficacy of PED using the EndoRotor device. METHODS: This was an Institutional Review Board-approved, multicenter, retrospective review. Patients underwent PED with the EndoRotor device from August 2018 to September 2019 at 4 high-volume U.S. centers. Patient demographics, indication for PED, and procedural and histopathologic data were recorded. RESULTS: Thirty-four patients underwent PED (41 lesions). The most common indications for PED were colon polyps (18, 52.9%) and Barrett's esophagus (8, 23.5%). Most lesions (35, 85.4%) were resected previously for the same indication using standard techniques. Technical success was achieved in 97.6% of lesions (n = 40). Clinical success was achieved in most patients who underwent a follow-up examination (19, 79.2%). Intraprocedural bleeding (in 10 patients) was managed endoscopically; no EndoRotor-related perforations occurred. Three postprocedural adverse events occurred: self-limited chest pain in 1 patient and delayed bleeding in 2. CONCLUSIONS: The EndoRotor is a novel, effective, and safe PED device for endoscopic resection of flat and polypoid lesions in the colon and foregut. It may have a promising role in the endoscopic management of naïve and scarred mucosal lesions based on this initial experience. Further prospective studies are needed to clarify its role in endoluminal resection.

Initial multicenter experience with nitrous oxide cryoballoon for treatment of flat duodenal adenomas (with video).

BACKGROUND AND AIMS: EMR is the preferred endoscopic therapy for duodenal adenomas (DAs) but is associated with an overall adverse event rate of 26%. Cryotherapy using a Cryoballoon Focal Ablation System (CbFAS) can safely and effectively eradicate esophageal intestinal metaplasia. We report our first experience with cryoballoon ablation for treatment of flat DAs. METHODS: This was an American, multicenter, retrospective study involving 5 centers. DAs (Paris 0-IIa and 0-IIb) were treated with nitrous oxide for 5 to 12 seconds using CbFAS. Follow-up EGD was performed at 3 to 12 months. RESULTS: Seventeen DAs (mean size, 22.7 ± 14.3 mm; 12 tubular, 5 tubulovillous) from 13 patients (mean age, 66.5 ± 9.99 years; 61.5% males) were included in the study. Thirteen of 17 DAs (76.5%) had failed previous treatment, and 4 of 17 (23.5%) were treatment naÏve. All procedures were technically successful and achieved a >50% decrease in size after cryoballoon ablation There was no increase in size or progression of disease for any lesions. Overall, treatment was completed in 15 of 17 patients, and recurrence-free survival was achieved in 12 of 17 (71%) after a median follow-up of 15.5 months (interquartile range [IQR], 6.8-19.4). The median cryoablation time per polyp was 4 minutes (IQR, 1-7.5 minutes), and the median total procedure time was 25 minutes (IQR, 22-30.5 minutes). There were no intra- or postprocedural adverse events. CONCLUSIONS: Nitrous oxide cryoballoon ablation of nonpolypoid DAs is feasible, with promising safety and efficacy.

Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS: We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. RESULTS: Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS: Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

Evaluating learning curves and competence in colorectal EMR among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis.

BACKGROUND AND AIMS: Data on colorectal EMR (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT). METHODS: This multicenter prospective study used a STAT to grade AEF training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship. RESULTS: Six AEFs (189 C-EMRs; mean per AEF, 31.5 ± 18.5) were included. Mean polyp size was 24.3 ± 12.6 mm, and mean procedure time was 22.6 ± 16.1 minutes. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All 6 AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs. CONCLUSIONS: A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relatively low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. These pilot data serve as an initial framework for competence threshold, and suggest the need for validated tools for formal C-EMR training assessment.

Practice patterns, techniques, and outcomes of flexible endoscopic myotomy for Zenker's diverticulum: a retrospective multicenter study.

BACKGROUND: Flexible endoscopic myotomy has been increasingly performed for Zenker's diverticulum using various endoscopic techniques and devices. The main aims of this study were to assess practice patterns and compare outcomes of endoscopic myotomy for Zenker's diverticulum. METHODS: Procedures performed at 12 tertiary endoscopy centers from 1/2012 to 12/2018 were reviewed. Patients (≥ 18 years) with Zenker's diverticulum who had dysphagia and/or regurgitation and underwent endoscopic myotomy were included. Outcomes assessed included technical success, clinical success, and adverse events. RESULTS: 161 patients were included. Traditional endoscopic septotomy was performed most frequently (137/161, 85.1 %) followed by submucosal dissection of the septum and myotomy (24/161, 14.9 %). The hook knife (43/161, 26.7 %) and needle-knife (33/161, 20.5 %) were used most frequently. Overall, technical and clinical success rates were 98.1 % (158/161) and 78.1 % (96/123), respectively. Adverse events were noted in 13 patients (8.1 %). There was no significant difference in technical and clinical success between traditional septotomy and submucosal dissection groups (97.1 % vs. 95.8 %, P = 0.56 and 75.2 % vs. 90.9 %, P  = 0.16, respectively). Clinical success was higher with the hook knife (96.7 %) compared with the needle-knife (76.6 %) and insulated tip knife (47.1 %). Outcomes were similar between centers performing > 20, 11 - 20, and ≤ 10 procedures. CONCLUSIONS: Flexible endoscopic myotomy is an effective therapy for Zenker's diverticulum, with a low rate of adverse events. There was no significant difference in outcomes between traditional septotomy and a submucosal dissection approach, or with centers with higher volume, though clinical success was higher with the hook knife.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study.

BACKGROUND: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. METHODS: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. RESULTS: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial.

INTRODUCTION: Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation (CBA) suggest its potential clinical utility. We evaluated the safety and efficacy of CBA in a multicenter study of patients with neoplastic BE. METHODS: In a prospective clinical trial, 11 academic and community centers recruited consecutive patients with BE of 1-6 cm length and low-grade dysplasia, high-grade dysplasia (HGD), or intramucosal adenocarcinoma (ImCA) confirmed by central pathology. Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment. A nitrous oxide cryoballoon focal ablation system was used to treat all visible columnar mucosa in up to 5 sessions. Study end points included complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year. RESULTS: One hundred twenty patients with BE with ImCA (20%), HGD (56%), or low-grade dysplasia (23%) were enrolled. In the intention-to-treat analysis, the CE-D and CE-IM rates were 76% and 72%, respectively. In the per-protocol analysis (94 patients), the CE-D and CE-IM rates were 97% and 91%, respectively. Postablation pain was mild and short lived. Fifteen subjects (12.5%) developed strictures requiring dilation. One patient (0.8%) with HGD progressed to ImCA, which was successfully treated with EMR. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in 1 biopsy, not confirmed by subsequent EMR. DISCUSSION: In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted (clinicaltrials.gov registration NCT02514525).