Title : Safety and feasibility of conscious sedation for EUS-directed transgastric ERCP (EDGE) in post-Roux-en-Y gastric bypass patients: First UK multicentre experience
Abstract:
Background and Aims: EDGE has transformed biliary access in post-Roux-en-Y gastric bypass (RYGB) patients, yet almost all published series describe procedures under general anaesthesia due to perceived aspiration risk and procedural tolerance. Where theatre and anaesthetic capacity are limited, this dependency creates significant access barriers. Whether EDGE can be safely performed under conscious sedation in ambulatory endoscopy suites remains unevaluated in a UK multicentre setting. We aimed to evaluate the technical feasibility, sedation safety, and longitudinal secondary outcomes of Stage 1 and Stage 2 EDGE under conscious sedation.
Methods: We retrospectively reviewed all consecutive RYGB patients undergoing EDGE under conscious sedation with titrated intravenous midazolam and fentanyl at two UK tertiary centres (Manchester University NHS Foundation Trust and University Hospitals Birmingham NHS Foundation Trust) between February 2022 and October 2025. Primary endpoints were LAMS placement technical success and immediate sedation-related adverse events (hypoxaemia <90%, reversal agent use, aspiration, or unplanned conversion to GA). Secondary endpoints included procedure duration, pre-Stage 2 LAMS migration, reintervention requirement, Stage 2 ERCP success and sedation mode, persistent gastro-gastric fistula, and 30-day post-procedural complications (bleeding, perforation, infection, surgery, or readmission).
Results: Twenty consecutive patients underwent EDGE under conscious sedation (median age 55.5 years; 70% female; 60% ASA II; 90% choledocholithiasis). A 20-mm LAMS was deployed in 95% (19/20) of procedures. Stage 1 technical success was 95% (19/20), with the single failure attributable to an inability to distend the excluded stomach rather than sedation intolerance. Median procedure time was 10 minutes. No immediate sedation-related adverse events occurred at either centre - no hypoxaemia, no reversal agent use, no aspiration, and no unplanned conversion to general anaesthesia. All patients were discharged from the endoscopy unit the same day.
Pre-Stage 2 LAMS migration occurred in 10.0% (2/20) and was successfully managed endoscopically without surgical intervention. Post-procedural bleeding, perforation, infection, and 30-day readmissions were 0% (0/20). Of 19 patients proceeding to Stage 2 ERCP, technical success was 100% (19/19), with 94.7% (18/19) also completed under conscious sedation, though one patient required general anaesthesia for the second stage following poor tolerance observed during Stage 1 - a finding that highlights the value of Stage 1 tolerance as an indicator for individualised anaesthetic planning. Persistent gastro-gastric fistula was evaluated in 11 patients and identified in 27.3% (3/11); all were asymptomatic with no clinically significant weight gain.
Conclusions: In this small multicentre retrospective cohort, EDGE appears feasible under conscious sedation in selected patients with RYGB, achieving 95% technical success with no observed immediate sedation-related adverse events, requirement for reversal agents, or unplanned conversion to general anaesthesia. These findings support the feasibility of a conscious-sedation pathway for selected patients, with potential benefits for procedural efficiency and resource utilisation. Anaesthetic planning should remain individualised, particularly for patients with higher airway risk or factors suggesting poor tolerance of conscious sedation. Larger prospective multicentre studies are required to confirm safety and define patient-selection criteria.
