iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.02.001
Christina S. Gainey MD, Govind Kallumkal MD, Judy A. Trieu MD, MPH, Kelly E. Hathorn MD, Todd H. Baron MD
{"title":"Single-session endoscopic retrograde cholangiopancreatography and endoscopic ultrasound—guided gallbladder drainage for management of biliary obstruction and gallbladder disease","authors":"Christina S. Gainey MD, Govind Kallumkal MD, Judy A. Trieu MD, MPH, Kelly E. Hathorn MD, Todd H. Baron MD","doi":"10.1016/j.igie.2025.02.001","DOIUrl":"10.1016/j.igie.2025.02.001","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Conventional management of biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) followed by cholecystectomy to prevent recurrent biliary events, particularly when the indication is choledocholithiasis. In nonsurgical candidates, endoscopic ultrasound (EUS)—guided gallbladder drainage (EUS-GBD) is a first-line alternative for gallbladder decompression. Single-session ERCP and EUS-GBD provides definitive management of biliary obstruction and prevention of future biliary adverse events (AEs) without the need for surgical cholecystectomy or repeat intervention. Our study is the first in the United States to evaluate outcomes of patients who underwent ERCP and EUS-GBD for management of both malignant and benign biliary disease.</div></div><div><h3>Methods</h3><div>This is a retrospective review of patients who underwent single-session ERCP and EUS-GBD at the University of North Carolina from January 1, 2014, to November 1, 2023. Patient demographics, comorbidities, procedure details, and follow-up were recorded. Outcomes included technical and clinical success, short and long-term AEs, need for reintervention, and death.</div></div><div><h3>Results</h3><div>During the study period, 37 patients were included. Indications for ERCP and EUS-GBD were choledocholithiasis and cholelithiasis in 24 patients, malignant biliary obstruction and concomitant cholecystitis in 9, and benign biliary stricture and concomitant cholecystitis in 4. The mean (standard deviation) Charlson Comorbidity Index was 7.1 (2.6). Technical success for EUS-GBD was 97.3%, and overall clinical success for combined ERCP and EUS-GBD was 86.5%. Three early (8.1%) and 1 late (2.7%) AEs occurred. Early AEs included stent misdeployment, duodenal perforation, and post-ERCP fever. The late AE involved stent migration. None of the AEs resulted in mortality. Mean follow-up time was 312 (407) days. Four patients (10.8%) required a procedure for reintervention and 1 patient required a follow-up surgery. No patients required a follow-up surgical cholecystectomy.</div></div><div><h3>Conclusions</h3><div>Single-session ERCP and EUS-GBD appears effective for the management of both benign and malignant biliary obstruction and concomitant gallbladder disease with minimal AEs and without the need for surgical cholecystectomy. Larger prospective studies are needed to confirm these early findings.</div></div>","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 105-109"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.008
Benjamin Charles Norton MD , Apostolis Papaefthymiou MD , Andrea Telese MD , Alex Neiponice MD , Pablo Becerra Hoebel MD , Paulina Vignolo MD , Leonardo A. Rodriguez Grunert MD , Rehan Haidry MD
{"title":"Radiofrequency vapor ablation for duodenal mucosal ablation in the treatment of type 2 diabetes: results from the first-in-human pilot study","authors":"Benjamin Charles Norton MD , Apostolis Papaefthymiou MD , Andrea Telese MD , Alex Neiponice MD , Pablo Becerra Hoebel MD , Paulina Vignolo MD , Leonardo A. Rodriguez Grunert MD , Rehan Haidry MD","doi":"10.1016/j.igie.2025.03.008","DOIUrl":"10.1016/j.igie.2025.03.008","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Duodenal mucosal ablation (DMA) is an emerging endoscopic treatment modality for type 2 diabetes (T2D). The radiofrequency vapor ablation (RFVA) system (Aqua Medical Inc, Pleasanton, Calif, USA) is a single-use, through-the-scope, circumferential ablation catheter under investigation for DMA. In this pilot study, we assessed the safety, tolerability, procedural feasibility, and initial efficacy of RFVA.</div></div><div><h3>Methods</h3><div>We conducted a first-in-human, prospective, single-center trial enrolling 27 patients with poorly controlled T2D (glycated hemoglobin [HbA1c], 7.5%-10%) despite ≥1 oral antidiabetic drug. DMA was performed with the patient under anesthesia in several dose titrations as follows: safety cohort (180 J once, n = 2), first treatment cohort (180 J twice, n = 11), and second treatment cohort (200 J twice; n = 14). Primary outcomes were safety (number of serious adverse events [SAEs]), tolerability (based on a visual analog scale [VAS] pain score), feasibility (procedure time), and initial efficacy (change in HbA1c at 4, 12, and 24 weeks).</div></div><div><h3>Results</h3><div>Twenty-seven patients with a mean T2D duration of 6 years (standard deviation [SD], 2.6) underwent DMA with 100% technical success. Mean patient age was 54 years (SD, 6.6), 48% were men, and baseline HbA1c was 8.6% (SD, 0.6). Mean procedure time was 49.7 minutes (SD, 14.3) and catheter time 34.5 minutes (SD, 10.9). There were no SAEs, and the maximum mean VAS pain score was 1.4 (SD, 2.1) on day 2. We observed a change in HbA1c at 4 weeks (–0.9%), 12 weeks (–1.2%), and 24 weeks (–0.8%) after the procedure.</div></div><div><h3>Conclusions</h3><div>DMA using the RFVA system is a simple through-the-scope procedure that appears safe, well tolerated, and feasible for the treatment of T2D. (Clinical trial registration number: NCT05887635.)</div></div>","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 110-119"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.012
Celine B.E. Busch MD , Kim van den Hoek MD , Annieke C.G. van Baar MD, PhD , Suzanne Meiring MD, PhD , Thomas A. Bouwmeester MD, PhD , Frits Holleman MD, PhD , Max Nieuwdorp MD, PhD , Jacques J.G.H.M. Bergman MD, PhD
{"title":"Durable insulin elimination after duodenal re-cellularization via electroporation therapy combined with glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes","authors":"Celine B.E. Busch MD , Kim van den Hoek MD , Annieke C.G. van Baar MD, PhD , Suzanne Meiring MD, PhD , Thomas A. Bouwmeester MD, PhD , Frits Holleman MD, PhD , Max Nieuwdorp MD, PhD , Jacques J.G.H.M. Bergman MD, PhD","doi":"10.1016/j.igie.2025.03.012","DOIUrl":"10.1016/j.igie.2025.03.012","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Re-cellularization via electroporation therapy (ReCET) is an endoscopic procedure that uses electroporation to induce cellular apoptosis and subsequent re-epithelization in the duodenum. ReCET has demonstrated a positive effect on glycaemia. In this study, a single ReCET procedure was combined with a glucagon-like peptide-1 receptor agonist (GLP-1RA) with the goal of eliminating insulin treatment in patients with type 2 diabetes (T2D). At 12 months 86% of patients remained off insulin. Here we report the longer-term efficacy and safety of ReCET combined with GLP-1RA over 24 months.</div></div><div><h3>Methods</h3><div>This was a first-in-human study in patients with T2D on basal insulin (28-75 years of age; body mass index, 24-40 kg/m<sup>2</sup>; hemoglobin A<sub>1c</sub> [HbA<sub>1c</sub>], ≤64 mmol/mol; C-peptide, ≥0.2 nmol/L). All of the patients underwent ReCET, after which insulin was discontinued and semaglutide (GLP-1RA) was initiated. The follow-up was extended to 24 months for initial responders (off insulin and HbA<sub>1c</sub> ≤58 mmol/mol at 12 months). Primary end points were number of responders (efficacy) and number of adverse events, serious adverse events, and hypoglycemic events (safety). Secondary end points included glycemic, metabolic, and cardiovascular parameters, and treatment satisfaction scores.</div></div><div><h3>Results</h3><div>Fourteen patients underwent endoscopic ReCET. Eleven initial responders completed the 24-month follow-up, of which 1 withdrew consent after 18 months. All patients remained off insulin with adequate glycemic control. No procedure-related serious adverse events or severe hypoglycemic events were observed during 24 months of follow-up. Homeostatic model assessment of insulin resistance and liver fat percentage improved significantly compared with baseline.</div></div><div><h3>Conclusions</h3><div>These results suggest that duodenal ReCET combined with semaglutide is durable, allowing insulin elimination up to 24 months, and appears safe. Glycemic control was maintained, and metabolic health improved during the 24-month follow-up period.</div></div>","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 120-128.e1"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.011
Todd H. Baron MD, MASGE , Phillip S. Ge MD, FASGE
{"title":"A lifetime of pushing boundaries: thinking outside the box to endoscopically treat complex gastrointestinal diseases","authors":"Todd H. Baron MD, MASGE , Phillip S. Ge MD, FASGE","doi":"10.1016/j.igie.2025.03.011","DOIUrl":"10.1016/j.igie.2025.03.011","url":null,"abstract":"","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 167-193"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.014
Yervant Ichkhanian MD , Hashem N. Albunni MBBS , Aditya Gutta MD , James L. Watkins MD , Evan L. Fogel MD , Jeffrey J. Easler MD , Nasir Saleem MD , Mark A. Gromski MD
{"title":"The evolution of single-use duodenoscope utilization at a large-volume endoscopic retrograde cholangiopancreatography tertiary care center","authors":"Yervant Ichkhanian MD , Hashem N. Albunni MBBS , Aditya Gutta MD , James L. Watkins MD , Evan L. Fogel MD , Jeffrey J. Easler MD , Nasir Saleem MD , Mark A. Gromski MD","doi":"10.1016/j.igie.2025.03.014","DOIUrl":"10.1016/j.igie.2025.03.014","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Previous studies have shown promising outcomes with single-use duodenoscopes, often examining only 1 version. The aim of this study was to evaluate the long-term outcomes across multiple models at a large referral center.</div></div><div><h3>Methods</h3><div>Endoscopic retrograde cholangiopancreatography (ERCP) cases (July 2020-September 2023) were retrospectively reviewed to assess technical success, defined as successful cannulation without switching devices. A 3-tier system guided the use of single-use duodenoscopes: recommended for drug-resistant cases (Tier 1), considered for immunosuppressed patients (Tier 2), and discouraged in routine cases (Tier 3).</div></div><div><h3>Results</h3><div>Of 8375 ERCPs, 267 (3.2%) involved single-use duodenoscopes (Tier 1, 25%; Tier 2, 54%; and Tier 3, 21%). The majority focused on the biliary system (91%), with 9% targeting the pancreatic duct. Technical success was achieved in 94%. Technical failures were primarily due to poor imaging (53%) and inadequate maneuverability (47%). Adverse events were reported in 3% of cases. A gradual increase was observed in ERCPs using single-use duodenoscopes, from 2.6% in 2020 to 4.7% in 2023, alongside a notable decrease in Tier 3 usage from 29% to 14%. The use for native papillae rose from 9.8% to 21%, while pancreatic duct interventions dropped significantly from 15% to 4.8%. Junior faculty performed 84% of procedures, reporting greater satisfaction than senior faculty. Improvements in scope stiffness, image stability, and elevator functionality were noted with newer iterations.</div></div><div><h3>Conclusions</h3><div>This study offers real-world evidence of successful single-use duodenoscope integration into a high-volume practice, with growing use and increased endoscopist satisfaction over time.</div></div>","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 139-148"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.006
Peter Draganov MD, MASGE , Dennis Yang MD, FASGE , Vivek Kaul MD, FASGE
{"title":"Mentorship in advanced endoscopy: a conversation with Peter Draganov and Dennis Yang","authors":"Peter Draganov MD, MASGE , Dennis Yang MD, FASGE , Vivek Kaul MD, FASGE","doi":"10.1016/j.igie.2025.03.006","DOIUrl":"10.1016/j.igie.2025.03.006","url":null,"abstract":"","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 198-202"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
iGIEPub Date : 2025-06-01DOI: 10.1016/j.igie.2025.03.001
Scott VanderMeer BS , Linda S. Lee MD
{"title":"Newer kid on the block","authors":"Scott VanderMeer BS , Linda S. Lee MD","doi":"10.1016/j.igie.2025.03.001","DOIUrl":"10.1016/j.igie.2025.03.001","url":null,"abstract":"","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 194-197"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144322114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}