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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Papillary Balloon Dilation; Bile Duct Stones; Endoscopic Sphincterotomy; Stone Recurrence
• Intervention / Treatment: Procedure: ERCP

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Greece
  • Heraklion, Greece, 71409
    • ''Benizelion" General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST; Other Names: endoscopic papillary balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Venizelio General Hospital
• Investigators: Study Director: Gregorios Gregorios, Director, ''Benizelion" General Hospital, Heraklion, Crete

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): August 29, 2020
• Study Completion (Actual): August 29, 2020

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: endoscopic papillary balloon dilation; Stone recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Recurrence; Calculi; Dilatation, Pathologic
• Other Study ID Numbers: Paspatis-balloon dilation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No