Successful endoscopic removal of high-power magnetic balls embedded in the duodenal wall.

The dangers of magnet ingestion are well known. When multiple magnets are ingested, interventional removal is often necessary to prevent and/or treat complications. Despite reports of both endoscopic and surgical techniques in the literature, there is a lack of clear guidance on the best method for removal of high-power magnets when they are embedded within the intestinal wall (increasing concern for fistulation, perforation, and bowel wall necrosis). This case demonstrates the successful endoscopic removal of magnetic balls incidentally identified on X-ray and found to be embedded in the duodenal wall in a critically ill 2-year-old patient. Endoscopic removal can be considered in similar situations, if all resources (interventional endoscopy and pediatric surgery) are available to proceed safely.

Development and initial validation of a video-based peroral endoscopic myotomy assessment tool.

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.

Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial.

BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

Colorectal endoscopic submucosal dissection in the West: A systematic review and meta-analysis.

Background and study aims The advantages of endoscopic submucosal dissection (ESD) over endoscopic mucosal resection for large colorectal neoplasms are well established; however, the technical challenges and lack of adequate training in ESD limit its widespread adoption in Western countries. Methods A literature search was performed in Medline, Embase, Web of Science, and the Cochrane Library for studies conducted in non-Asian countries evaluating the effectiveness of colorectal ESD. A random effects model was used to obtain pooled en bloc, R0 resection rates, and adverse events (AEs). Results Thirty-three studies comprising 3,958 ESD procedures met the inclusion criteria. Of the polyps, 96.7% (2,817 of 2913) were ≥ 2 cm. Pooled en bloc resection (31 studies), R0 resection (29 studies), and curative resection rates were 84.6% (95% confidence interval [CI] [83.3%-85.9%]), 75.6% (95% CI [74.1%-77.0%]), and 81.9% (95% CI [78.6%-84.9%]), respectively. Surgery for invasive cancer was performed in 4.8% (23 studies). ESD-related perforation (25 studies) was observed in 5.5% and bleeding in 4.1% (delayed bleeding 3.4%). 1.8% of patients underwent surgery for procedure-related complications. A high degree of heterogeneity was observed for en bloc resection, R0 resection, and curative resection. Heterogeneity for AEs (perforation [I 2 13%], delayed bleeding [I 2 30%], and overall bleeding [I 2 49%]) was low to moderate. Conclusions The effectiveness of colorectal ESD for large colorectal polyps and early colorectal cancers is improving in Western countries, and recent resection rates are comparable to that seen in Asia. Colorectal perforation is still observed in about 5% of ESD; however, < 2% of patients need emergency surgery for AEs.

Long-term outcomes of Zenker's peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum.

Background and study aims Z-POEM is now an established therapy for symptomatic Zenker's diverticulum (ZD). Short-term follow-up of up to 1-year post Z-POEM suggests excellent efficacy and safety; however, long-term outcomes are not known. Thus, we sought to report on longer-term outcomes (≥ 2 years) following Z-POEM for treatment of ZD. Patients and methods This was an International multicenter retrospective study at eight institutions across North America, Europe, and Asia over a 5-year period (from December 3, 2015 to March 13, 2020) of patients who underwent Z-POEM for management of ZD with a minimum 2-year follow-up. The primary outcome was clinical success, defined as improvement in dysphagia score to ≤ 1 without need for further procedures during the first 6 months. Secondary outcomes included rate of recurrence in patients initially meeting clinical success, rate of reintervention, and adverse events (AEs). Results A total of 89 patients (male 57.3 %, mean age 71 ±â€Š12 years) underwent Z-POEM for treatment of ZD (mean diverticulum size was 3.4 ±â€Š1.3 cm). Technical success was achieved in 97.8 % of patients (n = 87) with a mean procedure time of 43.8 ±â€Š19.2 minutes. The median post-procedure hospital stay was 1 day. There were eight AEs (9 %) (3 mild, 5 moderate). Overall, clinical success was achieved in 84 patients (94 %). Mean dysphagia, regurgitation, and respiratory scores all improved dramatically from 2.1 ±â€Š0.8, 2.8 ±â€Š1.3, and 1.8 ±â€Š1.6 pre-procedure to 0.13 ±â€Š0.5, 0.11 ±â€Š0.5, and 0.05 ±â€Š0.4, respectively, post-procedure at most recent follow-up (all P  < 0.0001). Recurrence occurred in six patients (6.7 %) during a mean length of follow-up of 37 months (range 24 to 63 months). Conclusions Z-POEM is a highly safe and effective treatment for Zenker's diverticulum with durable treatment effect to at least 2 years.

Through-the-scope suture closure of nonampullary duodenal endoscopic mucosal resection defects: a retrospective multicenter cohort study.

BACKGROUND: Delayed bleeding is among the most common adverse events associated with endoscopic mucosal resection (EMR) of nonampullary duodenal polyps. We evaluated the rate of delayed bleeding and complete defect closure using a novel through-the-scope (TTS) suturing system for the closure of duodenal EMR defects. METHODS: We reviewed the electronic medical records of patients who underwent EMR for nonampullary duodenal polyps of ≥ 10 mm and prophylactic defect closure with TTS suturing between March 2021 and May 2022 at centers in the USA. We evaluated the rates of delayed bleeding and complete defect closure. RESULTS: 36 nonconsecutive patients (61 % women; mean [SD] age, 65 [12] years) underwent EMR of ≥ 10-mm duodenal polyps followed by attempted defect closure with TTS suturing. The mean (SD) lesion size was 29 (19) mm, defect size was 37 (25) mm; eight polyps (22 %) involved > 50 % of the lumen circumference. Complete closure was achieved in all cases (78 % with TTS suturing alone), using a median of one TTS suturing kit. There were no cases of delayed bleeding and no adverse events attributed to application of the TTS suturing device. CONCLUSION: Prophylactic closure of nonampullary duodenal EMR defects using TTS suturing resulted in a high rate of complete closure and no delayed bleeding events.

Novel through-the-scope suture closure of colonic EMR defects (with video).

BACKGROUND AND AIMS: Large colon polyps removed by EMR can be complicated by delayed bleeding. Prophylactic defect clip closure can reduce post-EMR bleeding. Larger defects can be challenging to close using through-the-scope clips (TTSCs), and proximal defects are difficult to reach using over-the-scope techniques. A novel, through-the-scope suturing (TTSS) device allows direct closure of mucosal defects without scope withdrawal. The goal of this study was to evaluate the rate of delayed bleeding after the closure of large colon polyp EMR sites with TTSS. METHODS: A multicenter retrospective cohort study was performed involving 13 centers. All defect closure by TTSS after EMR of colon polyps ≥2 cm from January 2021 to February 2022 were included. The primary outcome was rate of delayed bleeding. RESULTS: A total of 94 patients (52% female; mean age, 65 years) underwent EMR of predominantly right-sided (n = 62 [66%]) colon polyps (median size, 35 mm; interquartile range, 30-40 mm) followed by defect closure with TTSS during the study period. All defects were successfully closed with TTSS alone (n = 62 [66%]) or with TTSS and TTSCs (n = 32 [34%]), using a median of 1 (interquartile range, 1-1) TTSS system. Delayed bleeding occurred in 3 patients (3.2%), with 2 requiring repeated endoscopic evaluation/treatment (moderate). CONCLUSION: TTSS alone or with TTSCs was effective in achieving complete closure of all post-EMR defects, despite a large lesion size. After TTSS closure with or without adjunctive devices, delayed bleeding was seen in 3.2% of cases. Further prospective studies are needed to validate these findings before wider adoption of TTSS for large polypectomy closure.

Zenker's peroral endoscopic myotomy for management of large Zenker's diverticulum.

BACKGROUND: Zenker's diverticulum peroral endoscopic myotomy (zPOEM) is a minimally invasive treatment strategy for Zenker's diverticulum, with excellent results for management of small-to-moderate Zenker's diverticulum. We evaluated its use in the management of large Zenker's diverticulum. METHODS: This was a retrospective multicenter cohort study across 11 international centers including adult patients with large Zenker's diverticulum ≥ 40 mm treated by zPOEM between March 2017 and March 2022. The primary outcome was clinical success (dysphagia score ≤ 1 without need for further intervention). Secondary outcomes included technical success (complete myotomy as intended), adverse events (AEs), and rate of recurrence. RESULTS: 83 patients (male 62.7 %, mean age 72.6 [SD 11.5] years) underwent zPOEM for treatment of large Zenker's diverticulum (median size 50 mm, interquartile range [IQR] 41-55 mm, range 40-80 mm). The zPOEM procedure was technically successful in 82 patients (98.8 %), with a mean procedure time of 48.7 (SD 23.2) minutes. Clinical success was achieved in 71 patients (85.5 %). Median (IQR) symptom scores improved significantly from baseline for dysphagia (2 2 3 vs. 0 [0-2]; P < 0.001), regurgitation (3 2 3 4 vs. 0 [0-0]; P < 0.001), and respiratory symptoms (2 [0-3] vs. 0 [0-0]; P < 0.001). Among patients achieving clinical success, only one recurrence (1.4 %) was recorded during a median follow-up of 12.2 months (IQR 3-28). Post-procedure AEs, all mild to moderate, occurred in four patients (4.8 %). CONCLUSION: This study demonstrated safe and effective use of zPOEM in the management of large Zenker's diverticulum.

Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that treat early rectal cancer (ERC). Both are effective treatments, yet there are very few studies comparing them. The aim of our study was to identify ideal candidates for each procedure. MATERIALS AND METHODS: Between January 2016 and November 2019, 204 ERC patients were managed with either ESD (n=101) or TEM (n=103) at 7 international centers. Data analyzed included clinical success, tumor characteristics, procedure info, and recurrence rates. RESULTS: Median tumor size was 40 mm±23.9 in the ESD group and 56 mm±27.9 in the TEM group, significantly larger in the latter ( P <0.00001). Average procedure time was 131.5±67.9 minutes in ESD group and 104.9±28.4 minutes in TEM group ( P =0.000347). Average hospital stay was 3.3±2.6 days in the ESD group and 4.7±0.7 days in the TEM group ( P <0.00001). Adverse event rate was 6.8% in the ESD group and 24% in the TEM group. There were no significant difference in the rate of en bloc resection, technical success, tumor location, necessity of additional procedures, and tumor recurrence rates. CONCLUSION: Compared with TEM, ESD is a safer procedure with shorter hospital stay and should be offered for patients who have ERC.

Subepithelial tumors: How does endoscopic full-thickness resection & submucosal tunneling with endoscopic resection compare with laparoscopic endoscopic cooperative surgery?

Background and study aims Endoscopic techniques are rapidly emerging for resection of subepithelial tumors (SETs). Submucosal tunneling for endoscopic resection (STER), endoscopic full-thickness resection (EFTR) and laparoscopic endoscopic cooperative surgery (LECS) are current alternatives to open surgery. In this study, we aimed to compare the three endoscopic techniques. Patients and methods Consecutive patients who underwent resection of a submucosal esophageal or gastric lesion at several tertiary care centers were included in a dedicated registry over 3 years. Demographics, size and location of resected lesion, histology of specimen, length of procedure, adverse events (AEs), duration of hospital stay, and follow-up data were collected. Results Ninety-six patients were included (47.7 % male, mean age 62): STER n = 34, EFTR n = 34, LECS n = 280. The lesions included leiomyoma, gastrointestinal stromal tumors (GISTs) and other. The mean lesion size was 28 mm (STD 16, range 20-72 mm). The majority of lesions in the EFTR and laparoscopic-assisted resection group were GISTs. There was no significant difference in clear resection margins, post-procedure complication rates, recurrence rate and total follow-up duration between the groups. However, the LECS group had a procedure time at least 30 minutes longer than STER or EFTR ( P  < 0.01). Total hospital stay for the laparoscopic-assisted resection group was also longer when compared to STER (1.5) and EFTR (1.8) ( P  < 0.01). Conclusions STER, EFTR, and laparoscopic-assisted resection are efficacious approaches for resection of SETs with similar R0 resection rates, complication rates, and AE rates. Laparoscopic assisted resection appears more time-consuming and is associated with a longer hospital stay.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Endoscopic submucosal dissection for colorectal dysplasia in inflammatory bowel disease: a US multicenter study.

Background and study aims In patients with inflammatory bowel disease (IBD), endoscopically visible lesions with distinct borders can be considered for endoscopic resection. The role of endoscopic submucosal dissection (ESD) for these lesions is not well defined because of a paucity of data. We aimed to evaluate the outcomes of colorectal ESD of dysplastic lesions in patients with IBD across centers in the United States. Patients and methods This was a retrospective analysis of consecutive patients with IBD who were referred for ESD of dysplastic colorectal lesions at nine centers. The primary endpoints were the rates of en bloc resection and complete (R0) resection. The secondary endpoints were the rates of adverse events and lesion recurrence. Results A total of 45 dysplastic lesions (median size 30mm, interquartile range [IQR] 23 to 42 mm) in 41 patients were included. Submucosal fibrosis was observed in 73 %. En bloc resection was achieved in 43 of 45 lesions (96 %) and R0 resection in 34 of 45 lesions (76 %). Intraprocedural perforation occurred in one patient (2.4 %) and was treated successfully with clip placement. Delayed bleeding occurred in four patients (9.8 %). No severe intraprocedural bleeding or delayed perforation occurred. During a median follow-up of 18 months (IQR 13 to 37 months), local recurrence occurred in one case (2.6 %). Metachronous lesions were identified in 11 patients (31 %). Conclusions ESD, when performed by experts, is safe and effective for large, dysplastic colorectal lesions in patients with IBD. Despite the high prevalence of submucosal fibrosis, en bloc resection was achieved in nearly all patients with IBD undergoing ESD. Careful endoscopic surveillance is necessary to monitor for local recurrence and metachronous lesions after ESD.

Celiac Plexus Neurolysis Is Associated With Decreased Survival in Patients With Pancreatic Cancer: A Propensity Score Analysis.

OBJECTIVE: The aim of this study was to investigate survival in patients who received celiac plexus neurolysis (CPN) compared with patients who received opioids. METHODS: The Surveillance, Epidemiology and End Results-Medicare database was used to identify patients older than 65 years diagnosed with pancreatic cancer between 2007 and 2015. We used claims data to identify patients with a history of CPN and opioid use within 1 year of diagnosis, and other demographic, clinical, and treatment variables. Kaplan-Meier analyses and inverse propensity-weighted adjusted Cox proportional hazard ratios were used to evaluate survival. RESULTS: We identified 648 patients who underwent CPN (19.0%) compared with 2769 patients who received opioids (81.0%). The median survival and interquartile range for patients who received CPN was 4.0 months (2.0-8.0 months) compared with 7.0 months (3.0-12.0 months) for opioid users (P < 0.0001). After adjusting for confounders and propensity score, the patients who received CPN showed worsened survival (hazard ratio, 1.69; 95% confidence interval, 1.59-1.79). CONCLUSIONS: Pancreatic cancer patients who underwent CPN had decreased survival compared with opioid users. This suggests that opioid sparing methods to reduce pancreatic cancer pain may actually be harmful. Future prospective studies should investigate whether other opioid sparing therapies impact pancreatic cancer survival.

Devices for esophageal function testing.

BACKGROUND AND AIMS: Esophageal function testing is an integral component of the evaluation of refractory GERD and esophageal motility disorders. This review summarizes the current technologies available for esophageal function testing, including the functional luminal imaging probe (FLIP), high-resolution esophageal manometry (HRM), and multichannel intraluminal impedance (MII) and pH monitoring. METHODS: We performed a MEDLINE, PubMed, and MAUDE database literature search to identify pertinent clinical studies through March 2021 using the following key words: esophageal manometry, HRM, esophageal impedance, FLIP, MII, and esophageal pH testing. Technical data were gathered from traditional and web-based publications, proprietary publications, and informal communications with pertinent vendors. The report was drafted, reviewed, and edited by the American Society for Gastrointestinal Endoscopy Technology Committee and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy. RESULTS: FLIP is a high-resolution impedance planimetry system used for pressure and dimension measurement in the esophagus, pylorus, and anal sphincter. FLIP provides complementary information to HRM for esophageal motility disorders, especially achalasia. The Chicago classification, based on HRM data, is a widely adopted algorithmic scheme used to diagnose esophageal motility disorders. MII detects intraluminal bolus movement and, combined with pH measurement or manometry, provides information on acid and non-acid gastroesophageal reflux and bolus transit in patients with refractory GERD and for preoperative evaluation for anti-reflux procedures. CONCLUSIONS: Esophageal function testing techniques (FLIP, HRM, and MII-pH) have diagnostic and prognostic value in the evaluation of esophageal motility disorders and refractory GERD. Newer technologies and classification systems have enabled an increased understanding of these diseases.

Use of endoscopic ultrasound for pancreatic cancer from 2000 to 2016.

Background and study aims Pancreatic cancer (PC) is the fourth most common cause of cancer death in the United States. Previous studies have suggested a survival benefit for endoscopic ultrasound (EUS), an important tool for diagnosis and staging of PC. This study aims to describe EUS use over time and identify factors associated with EUS use and its impact on survival. Patients and methods This was a retrospective review of the Surveillance, Epidemiology and End Results (SEER) database linked with Medicare claims. EUS use, clinical and demographic characteristics were evaluated. Chi-squared analysis, Cochran-Armitage test for trend, and logistic regression were used to identify associations between sociodemographic and clinical factors and EUS. Kaplan-Meier and Cox proportional hazard ratios were used for survival analysis. Results EUS use rose during the time period, from 7.4 % of patients in 2000 to 32.4 % in 2015. Patient diversity increased, with a rising share of older, non-White patients with higher Charlson comorbidity scores. Both clinical (receipt of other therapies, PC stage) and nonclinical factors (region of country, year of diagnosis) were associated with receipt of EUS. While EUS was associated with a survival improvement early in the study period, this effect did not persist for PC patients diagnosed in 2012 to 2015 (median survival 3 month ± standard deviation [SD] 9.8 months without vs. 4 months ± SD 8 months with EUS). Conclusions Our data support previous studies, which suggest a survival benefit for EUS when it was infrequently used, but finds that benefit was attenuated as EUS became more widely available.