Risk of De Novo Barrett's Esophagus Post Sleeve Gastrectomy: A Systematic Review and Meta-Analysis of Studies with Long-Term Follow-Up.

BACKGROUND & AIMS: Sleeve gastrectomy (SG) is one of the most commonly performed bariatric procedures worldwide. Gastroesophageal reflux disease (GERD) is a major concern in patients undergoing SG and is a risk factor for Barrett's esophagus (BE). We conducted a systematic review and meta-analysis to assess the incidence of and analyze predictive factors for post-SG BE. METHODS: A comprehensive literature search was conducted in April 2024, for studies reporting on incidence of BE, erosive esophagitis (EE), and hiatal hernia (HH) post-SG. Primary outcomes were post-SG pooled rates of de novo BE, EE, GERD symptoms, proton pump inhibitor use, and HH. Meta-regression analysis was performed to assess if patient and post-SG factors influenced the rates of post-SG BE. RESULTS: Nineteen studies with 2046 patients (79% females) were included. Mean age was 42.2 years (standard deviation, 11.1) and follow-up ranged from 2 to 11.4 years. The pooled rate of de novo BE post-SG was 5.6% (confidence interval, 3.5-8.8). Significantly higher pooled rates of EE (risk ratio [RR], 3.37], HH (RR, 2.09), GER/GERD symptoms (RR, 3.32), and proton pump inhibitor use (RR, 3.65) were found among patients post-SG. GER/GERD symptoms post-SG positively influenced the pooled BE rates, whereas age, sex, body mass index, post-SG EE, and HH did not. CONCLUSIONS: Our analysis shows that SG results in a significantly increased risk of de novo BE and higher rates of EE, proton pump inhibitor use, and HH. Our findings suggest that clinicians should routinely screen patients with SG for BE and future surveillance intervals should be followed as per societal guidelines.

Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection).

INTRODUCTION: Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size. METHODS: We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates. RESULTS: A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00). DISCUSSION: Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

The 2023 top 10 list of endoscopy topics in medical publishing: an annual review by the American Society for Gastrointestinal Endoscopy Editorial Board.

Using a systematic literature search of original articles published during 2023 in Gastrointestinal Endoscopy (GIE) and other high-impact medical and gastroenterology journals, the GIE Editorial Board of the American Society for Gastrointestinal Endoscopy compiled a list of the top 10 most significant topic areas in general and advanced GI endoscopy during the year. Each GIE Editorial Board member was directed to consider 3 criteria in generating candidate topics-significance, novelty, and impact on global clinical practice-and subject matter consensus was facilitated by the Chair through electronic voting and a meeting of the entire GIE Editorial Board. The 10 identified areas collectively represent advances in the following endoscopic spheres: GI bleeding, endohepatology, endoscopic palliation, artificial intelligence and polyp detection, artificial intelligence beyond the colon, better polypectomy and EMR, how to make endoscopy units greener, high-quality upper endoscopy, endoscopic tissue apposition and closure devices, and endoscopic submucosal dissection. Each board member was assigned a topic area around which to summarize relevant important articles, thereby generating this overview of the "top 10" endoscopic advances of 2023.

The use of a self-assembling peptide gel for stricture prevention in the esophagus after endoscopic submucosal dissection: a U.S. multicenter prospective study (with video).

BACKGROUND AND AIMS: Postoperative stricture is a serious common adverse event after extensive endoscopic submucosal dissection (ESD) in the esophagus. Self-assembling peptide (SAP) gel has been shown to promote tissue healing and re-epithelialization. The aim of this study was to evaluate the effect of the SAP gel for esophageal stricture prevention after ESD. METHODS: This was a multicenter prospective study of patients who underwent esophageal ESD followed by SAP gel application between March 2022 and December 2023. Patients were included if the ESD mucosal defect involved ≥50% of the circumference of the esophagus. High-risk cases were defined as mucosal defects ≥75% of the circumference. Stricture was defined as the inability to pass an endoscope ≥8.9 mm in diameter or a narrow-caliber lumen in a patient with symptoms. RESULTS: A total of 43 patients (median age, 71 years; 81.4% male) underwent ESD (median resected specimen size, 50 mm) during the study period. SAP gel (median, 3 mL) was successfully applied in all cases (median time, 4 minutes). In aggregate, stricture occurred in 20.9% (9 of 43) of the cases. Stricture developed in 30.8% of the high-risk cases: 80% (4 of 5) after circumferential ESD and 19% (4 of 21) in those with defects ≥75% but <100% of the circumference. All cases of stricture resolved with endoscopic treatment. Three cases (6.9%) of postoperative bleeding occurred and were adequately managed endoscopically. CONCLUSIONS: We show that SAP gel application was easy, quick, and associated with a relatively low stricture rate comparable to other prophylactic methods. Additional comparative studies are needed to corroborate these preliminary findings.

Fixation of the proximal flange of a lumen-apposing metal stent using a through-the-scope endoscopic suturing system to prevent stent migration in single-session EUS-directed transgastric ERCP: a pilot study.

BACKGROUND AND AIMS: With the global obesity pandemic, clinical scenarios requiring urgent ERCP in patients with gastric bypass surgery are on the rise, and single-session EUS-directed transgastric ERCP (SS-EDGE) can effectively address these technical challenges. The aim of this study was to evaluate and describe the safe and effective use of a through-the-scope endoscopic suturing system for anchoring the lumen-apposing metal stents (LAMSs) during SS-EDGE. METHODS: Six patients with Roux-en-Y gastric bypass (RYGB) underwent SS-EDGE at our center. A through-the-scope endoscopic suturing system was used for anchoring the LAMSs during SS-EDGE. RESULTS: Clinical and technical success was achieved in all 6 patients without any adverse events related to the procedure. No stent migration, pneumoperitoneum, or GI perforation was noted. At the 4-week follow-up, no stent migration was noted, and the through-the-scope suturing system remained anchored. LAMSs along with tacks were removed, and gastric fistulae were successfully closed endoscopically in all patients to prevent weight gain. CONCLUSIONS: Use of through-the-scope endoscopic suturing can be a safe, reliable, and potentially cost-effective novel technique for LAMS fixation to successfully perform SS-EDGE in RYGB patients.

Peroral endoscopic myotomy for spastic esophageal dysmotility among opioid users: a multicenter propensity score matching study.

BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.

Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these SiOPs can result in elevated subvisible particle counts in PFS drug products compared to other drug presentations such as vials or cartridges. Their presence in products presents analytical challenges as they complicate quantitation and characterization of other types of subvisible particles in solution. Previous studies have suggested that they can potentially act as adjuvant resulting in potential safety risks for patients. In this paper we present several analytical case studies describing the impact of the presence of SiOPs in biotherapeutics on the analysis of the drug as well as clinical case studies examining the effect of SiOPs on patient safety. The analytical case studies demonstrate that orthogonal techniques, especially flow imaging, can help differentiate SiOPs from other types of particulate matter. The clinical case studies showed no difference in the observed patient safety profile across multiple drugs, patient populations, and routes of administration, indicating that the presence of SiOPs does not impact patient safety.

International Consensus Recommendations for Safe Use of LAMS for On- and Off-Label Indications Using a Modified Delphi Process.

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

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.

Low delayed bleeding and high complete closure rate of mucosal defects with the novel through-the-scope dual-action tissue clip after endoscopic resection of large nonpedunculated colorectal lesions (with video).

BACKGROUND AND AIMS: Complete closure after endoscopic resection of large nonpedunculated colorectal lesions (LNPCLs) can reduce delayed bleeding but is challenging with conventional through-the-scope (TTS) clips alone. The novel dual-action tissue (DAT) clip has clip arms that open and close independently of each other, facilitating tissue approximation. We aimed to evaluate the rate of complete closure and delayed bleeding with the DAT clip after endoscopic resection of LNPCLs. METHODS: This was a multicenter prospective cohort study of all patients who underwent defect closure with the DAT clip after EMR or endoscopic submucosal dissection (ESD) of LNPCLs ≥20 mm from July 2022 to May 2023. Delayed bleeding was defined as a bleeding event requiring hospitalization, blood transfusion, or any intervention within 30 days after the procedure. Complete closure was defined as apposition of mucosal defect margins without visible submucosal areas <3 mm along the closure line. RESULTS: One hundred seven patients (median age, 64 years; 42.5% women) underwent EMR (n = 63) or ESD (n = 44) of LNPCLs (median size, 40 mm; 74.8% right-sided colon) followed by defect closure. Complete closure was achieved in 96.3% (n = 103) with a mean of 1.4 ± .6 DAT clips and 2.9 ± 1.8 TTS clips. Delayed bleeding occurred in 1 patient (.9%) without requiring additional interventions. CONCLUSIONS: The use of the DAT clip in conjunction with TTS clips achieved high complete defect closure after endoscopic resection of large LNPCLs and was associated with a .9% delayed bleeding rate. Future comparative trials and formal cost-analyses are needed to validate these findings. (Clinical trial registration number: NCT05852457.).

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.

Endoscopic submucosal dissection with versus without traction for pathologically staged T1B esophageal cancer: a multicenter retrospective study.

BACKGROUND AND AIMS: Positive vertical margins (VMs) are common after endoscopic submucosal dissection (ESD) of T1b esophageal cancer (EC) and are associated with an increased risk of recurrence. Traction during ESD provides better exposure of the submucosa and may allow deeper dissection, potentially reducing the risk of positive VMs. We conducted a retrospective multicenter study to compare the proportion of resections with positive VMs in ESD performed with versus without traction in pathologically staged T1b EC. METHODS: Patients who underwent ESD revealing T1b EC (squamous or adenocarcinoma) at 10 academic tertiary referral centers in the United States (n = 9) and Brazil (n = 1) were included. Demographic and clinical data were abstracted. ESD using either traction techniques (tunneling, pocket) or traction devices (clip line, traction wire) were classified as ESD with traction (Tr-ESD) and those without were classified as conventional ESD without traction. The primary outcome was a negative VM. Multivariable logistic regression was used to assess associations with negative VMs. RESULTS: A total of 166 patients with pathologically staged T1b EC underwent Tr-ESD (n = 63; 38%) or conventional ESD without traction (n = 103; 62%). Baseline factors were comparable between both groups. On multivariable analysis, Tr-ESD was found to be independently associated with negative VMs (odds ratio, 2.25; 95% confidence interval, 1.06-4.91; P = .037) and R0 resection (odds ratio, 2.83; 95% confidence interval, 1.33-6.23; P = .008). CONCLUSION: Tr-ESD seems to be associated with higher odds of negative VMs than ESD without traction for pathologically staged T1b EC, and future well-conducted prospective studies are warranted to establish the findings of the current study.

The 2022 top 10 list of endoscopy topics in medical publishing: an annual review by the American Society for Gastrointestinal Endoscopy Editorial Board.

Using a systematic literature search of original articles published during 2022 in Gastrointestinal Endoscopy and other high-impact medical and gastroenterology journals, the 10-member Editorial Board of the American Society for Gastrointestinal Endoscopy composed a list of the 10 most significant topic areas in GI endoscopy during the study year. Each Editorial Board member was directed to consider 3 criteria in generating candidate lists-significance, novelty, and global impact on clinical practice-and subject matter consensus was facilitated by the Chair through electronic voting. The 10 identified areas collectively represent advances in the following endoscopic spheres: artificial intelligence, endoscopic submucosal dissection, Barrett's esophagus, interventional EUS, endoscopic resection techniques, pancreaticobiliary endoscopy, management of acute pancreatitis, endoscopic environmental sustainability, the NordICC trial, and spiral enteroscopy. Each board member was assigned a consensus topic area around which to summarize relevant important articles, thereby generating this précis of the "top 10" endoscopic advances of 2022.

AGA Clinical Practice Update on the Role of Artificial Intelligence in Colon Polyp Diagnosis and Management: Commentary.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert commentary on the current landscape of artificial intelligence in the evaluation and management of colorectal polyps. 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. This Expert Commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are experienced endoscopists with expertise in the field of artificial intelligence and colorectal polyps.

Novel devices for third-space endoscopy procedures.

Third-space endoscopy (TSE) is a subspecialty in interventional endoscopy that exploits the submucosa as a working space for the management of various gastrointestinal diseases. Over recent years, TSE has emerged as a viable alternative to surgery for the treatment of various conditions. The rapid dissemination and adoption of TSE has been largely supported by the advent of novel devices aimed to improve the efficacy and safety of these procedures. In this article, we review some of the recent developments in TSE devices and provide our initial experience with these instruments in clinical practice.

Initial multicenter experience using a novel articulating through-the-scope traction device for endoscopic submucosal dissection.

Background and study aims A single-operator, articulating, through-the-scope (TTS) traction device was recently developed to facilitate endoscopic submucosal dissection (ESD). Clinical data on the performance of this device are limited. We report an initial multicenter experience with ESD using this articulating TTS traction device. Patients and methods Retrospective analysis on all consecutive patients who underwent ESD using this traction device (T-ESD) at five centers between August 2021 and December 2022. Endpoints included: rates of en-bloc resection, R0 resection, curative resection, and adverse events. Results Thirty-six patients (median age 64.8 years; 47.2% women) underwent ESD (median lesion size 40 mm; interquartile range [IRQ]: 27.5-67.5) for lesions in the esophagus (n=2), stomach (n=8), sigmoid colon (n=6), and rectum (n=20). Submucosal fibrosis was encountered in one-third of the lesions (33.3%). Median ESD time was 104.6 minutes (IQR: 65-122). En-bloc, R0 and curative resection were achieved in 94.4%, 91.6%, and 97.2%, respectively. The single patient with non-curative resection of an invasive rectal adenocarcinoma underwent surgery. There were no cases of delayed bleeding or perforation. There was no recurrence on surveillance endoscopy (n=20) at a median of 6 months (IQR: 3.75-6). Conclusions This initial multicenter experience demonstrates high resection rates and excellent safety profile when performing ESD with this novel articulating TTS device. Dynamic real-time traction may lower the technical difficulty of ESD. Additional studies are needed to assess its cost-effectiveness and compare its usefulness with other traction devices and techniques during ESD.

Multicenter prospective evaluation of an overtube endoluminal interventional platform for colorectal polypectomy.

Background and study aims Endoscopic removal of complex colorectal polyps (≥ 2 cm) can be technically challenging. A dual balloon endoluminal overtube platform (DBEP) was developed to facilitate colonoscopic polypectomy. The study purpose was to evaluate clinical outcomes with the DBEP for complex polypectomy. Patients and methods This was an observational, prospective, multicenter Institutional Review Board-approved study. Between January 2018 and December 2020, safety and performance data were collected intra-procedurally and at 1 month post-procedure in patients undergoing intervention with the DBEP at three US centers. The primary endpoint was device safety and technical success of the procedure. Secondary endpoints included navigation time, total procedure time, and user feedback assessment post-procedure. Results A total of 162 patients underwent colonoscopy with the DBEP. Of these, 144 (89 %) underwent 156 interventions successfully with DBEP (44.5 % endoscopic mucosal resection, 53.2 % hybrid endoscopic submucosal dissection (ESD)/ESD, 1.3 % other). In 13 patients (8 %), device challenges contributed to unsuccessful intervention. One mild device-related adverse event (AE) occurred. Procedural AE rate was 8.3 %. Median lesion size was 2.6 cm [range 0.5-12]. The investigators felt that navigating the device was easy/somewhat easy in 78.5 % of successful cases. Median total procedure time was 69 minutes [range, 19-213], median navigation time to lesion was 8 minutes [range, 1-80], And median polypectomy time was 33.5 minutes [range, 2-143]. Conclusions Endoscopic colon polyp resection with the DBEP was safe with a high technical success rate. The DBEP has the potential to provide enhanced scope stability and visualization, traction, and a conduit for scope exchange. Further prospective randomized studies are warranted.