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

NCT06948279 | Completed

• 1 other identifier: 01066416087
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Choledocholithiasis; Bile Duct; ERCP; Elderly

Outcome Measures

Primary Outcomes (1)

• Rate of complete stone clearance

  complete removal of all detectable stones from the common bile duct without the need for additional procedures

  One month

Secondary Outcomes (1)

• ERCP-related adverse events

  Three months

Study Arms (2)

Group A (Stent-first Approach)

ACTIVE COMPARATOR

Group A patients had a temporary plastic stent placed to facilitate bile drainage, with elective stone removal scheduled 8-12 weeks later.

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

Group B (Stone Retrieval-first Approach)

PLACEBO COMPARATOR

In Group B, patients underwent immediate stone extraction attempts using conventional techniques such as basket, balloon, or mechanical lithotripsy as needed.

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

Interventions

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

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

Group A (Stent-first Approach)

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

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

Group B (Stone Retrieval-first Approach)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Charlson Comorbidity Index (CCI) ≥ 3
• Presence of large or multiple CBD stones (defined as ≥1 stone ≥15 mm or ≥3 stones each ≥10 mm on imaging)
• Ability to provide informed consent (or via legal representative).

You may not qualify if:

• Contraindications to ERCP or general anesthesia
• History of biliary surgery or altered anatomy
• Benign or malignant strictures of the distal CBD
• Intrahepatic bile duct stones
• Moderate to severe cholangitis
• Malignancy or serious condition with life expectancy \<6 months

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

National Liver Institute, Menoufia University, Egypt.

Shebeen El-Kom, Monufia Governorate, 32511, Egypt

Location

Related Publications (4)

• Tonozuka R, Itoi T, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Umeda J, Tanaka R, Honjyo M, Mukai S, Fujita M, Moriyasu F. Efficacy and safety of endoscopic papillary large balloon dilation for large bile duct stones in elderly patients. Dig Dis Sci. 2014 Sep;59(9):2299-307. doi: 10.1007/s10620-014-3156-9. Epub 2014 Apr 26.

  PMID: 24771320 BACKGROUND

• Kim KH, Kim TN. Efficacy and Safety of Endoscopic Papillary Large Balloon Dilation for Removal of Large Bile Duct Stones in Advanced Age. Can J Gastroenterol Hepatol. 2016;2016:6568989. doi: 10.1155/2016/6568989. Epub 2016 Oct 12.

  PMID: 27812520 BACKGROUND

• Ye X, Huai J, Sun X. Effectiveness and safety of biliary stenting in the management of difficult common bile duct stones in elderly patients. Turk J Gastroenterol. 2016 Jan;27(1):30-6. doi: 10.5152/tjg.2015.150305. Epub 2015 Dec 17.

  PMID: 26674978 BACKGROUND

• Meng K, Zhang DY, Chen DX, Liu WJ, Fang KX, Chen S, Wu L, Li MY. Large common bile duct stones in high-risk elderly patients: Immediate endoscopic stone removal or elective stone removal? A single-center retrospective study. BMC Gastroenterol. 2023 Oct 5;23(1):344. doi: 10.1186/s12876-023-02976-0.

  PMID: 37798726 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Jaundice, Obstructive

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

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

• Omkolsoum Alhaddad, M.D.

  National Liver Institute, Menoufia University Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatology and Gastroenterology

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: February 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)