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

NCT05191693 | Completed

• 1 other identifier: Paspatis-balloon dilation
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Papillary Balloon Dilation; Bile Duct Stones; Endoscopic Sphincterotomy; Stone Recurrence

Keywords

endoscopic papillary balloon dilation; Stone recurrence

Outcome Measures

Primary Outcomes (1)

• Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.

  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.

  22.4±6.2 months

Study Arms (1)

patients with CBD stones up to 8-12mm

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

Procedure: ERCP

Interventions

ERCP PROCEDURE

endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST

Also known as: endoscopic papillary balloon

patients with CBD stones up to 8-12mm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 ,who were prospectively followed for at least 12 months

Sponsors & Collaborators

• Venizelio General Hospital: lead

Study Sites (1)

''Benizelion" General Hospital

Heraklion, 71409, Greece

Location

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Gregorios Gregorios, Director

  ''Benizelion" General Hospital, Heraklion, Crete

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the gastroenterology department of Venizelio General Hospital

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 13, 2022
• Study Start: September 30, 2018
• Primary Completion: August 29, 2020
• Study Completion: August 29, 2020
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)