Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study

Completed

• Conditions: Bile Duct Stones; Endoscopic Papillary Balloon Dilation; Endoscopic Sphincterotomy; Stone Recurrence
• Interventions: Procedure: ERCP

• Registration Number: NCT05191693
• Lead Sponsor: Venizelio General Hospital

Brief Summary

The investigators prospectively evaluated long-term outcomes of ELBPD+EST for CBD stones up to 8-12mm.

EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Detailed Description

Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.

Overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%).

EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Study Timeline

• Study Start: 2018-09-30
• Primary Completion: 2020-08-29
• Study Completion: 2020-08-29
• Study First Submitted: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

patients with ELBPD+EST for CBD stones up to 8-12mm from September 2018 to August 2020 -

Exclusion Criteria

Patients with bile duct stones less than 8mm or more than 12mm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with CBD stones up to 8-12mm	ERCP	72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST

Primary Outcome Measures

Name	Time	Method
Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.	22.4±6.2 months	Patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.

Trial Locations

Locations (1)

''Benizelion" General Hospital; 🇬🇷 Heraklion, Greece