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Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients

NCT06948279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two different approaches for removing large or multiple stones from the common bile duct in older adults with chronic diseases. The main questions it aims to answer are:

Is it better to remove the stones immediately during the first endoscopic procedure? Or is it safer and more effective to place a temporary plastic stent first and remove the stones later?

Researchers will compare these two approaches to see which one leads to better stone clearance and fewer complications.

Participants will:

Undergo an endoscopic procedure (ERCP) to treat their bile duct stones. Be randomly assigned to either have immediate stone removal or have a stent placed first, with stone removal scheduled 8-12 weeks later.

Attend follow-up visits to monitor their recovery and check for complications.

This study is being conducted at the National Liver Institute, Menoufia University, Egypt.

Conditions

  • Choledocholithiasis
  • Jaundice, Obstructive

Interventions

PROCEDURE

The endoscopic retrograde cholangiopancreatography (ERCP) with insertion of a plastic stent.

A plastic stent was placed during the initial ERCP, with elective stone removal scheduled 8-12 weeks later.

PROCEDURE

The endoscopic retrograde cholangiopancreatography (ERCP) with immediate stone extraction attempts.

Immediate ERCP for stone removal, utilizing conventional techniques such as basket, balloon, or mechanical lithotripsy as needed.

Sponsors & Collaborators

  • National Liver Institute, Egypt

    lead OTHER

Principal Investigators

  • Omkolsoum Alhaddad, M.D. · National Liver Institute, Menoufia University Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-03-01
Completion
2024-09-01

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948279 on ClinicalTrials.gov