An interventional study of The endoscopic retrograde cholangiopancreatography (ERCP) with insertion of a plastic stent. and The endoscopic retrograde cholangiopancreatography (ERCP) with immediate stone extraction attempts. in Choledocholithiasis and Jaundice, Obstructive, sponsored by National Liver Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by National Liver Institute, Egypt · Not applicable, Interventional, and Treatment
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.
This study was designed to evaluate two different endoscopic treatment strategies for managing large or multiple common bile duct (CBD) stones in elderly patients considered high-risk due to age and comorbid conditions. The research was conducted at the National Liver Institute, Menoufia University in Egypt, a tertiary care center with a high volume of hepatobiliary cases and extensive expertise in endoscopic retrograde cholangiopancreatography (ERCP).
Study Design and Population This was a prospective, randomized, comparative clinical trial conducted between February 2022 and September 2024. A total of 400 patients aged 65 years or older, with a Charlson Comorbidity Index (CCI) ≥ 3 and radiologically confirmed large or multiple CBD stones, were enrolled. Large stones were defined as those with a diameter ≥15 mm; multiple stones were defined as three or more stones, each measuring ≥10 mm. Stone size and number were confirmed by computed tomography (CT) or magnetic resonance cholangiopancreatography (MRCP).
Eligible patients were randomly assigned in a 1:1 ratio to one of two groups:
Group A (Stent-first approach): Underwent initial biliary stenting followed by elective stone extraction 8-12 weeks later.
Group B (Stone retrieval-first approach): Underwent immediate endoscopic stone removal during the index ERCP.
Study Procedures and Intervention Details All participants underwent a standardized baseline assessment, including a comprehensive medical history, physical examination, laboratory testing (e.g., liver enzymes, complete blood count, coagulation profile), and imaging studies. Randomization was computer-generated and concealed from the enrolling clinical team to minimize selection bias. While blinding of patients and proceduralists was not feasible due to the nature of the interventions, outcome assessments-including imaging reviews and complication monitoring-were conducted by independent investigators who were blinded to treatment allocation.
ERCP procedures were performed using a side-viewing endoscope (Pentax ED-3490TK). In all patients, endoscopic sphincterotomy (EST) was performed, and selective CBD cannulation was achieved using standard or alternative techniques when necessary. In Group A, a 10 Fr, 10 cm plastic biliary stent was placed, with a follow-up ERCP scheduled after 8-12 weeks for elective stone removal. In Group B, stone extraction was attempted during the index ERCP using a balloon, Dormia basket, or mechanical lithotripsy. A stent was placed only if stone extraction was incomplete.
Calculation of Stone Burden CBD stone dimensions were measured from radiographic images, with adjustments for magnification using the endoscope diameter as a reference. The total stone burden, or stone index, was calculated as the sum of all stone diameters in centimeters. Two independent radiologists reviewed and averaged the measurements to ensure accuracy and objectivity.
Assessments and Follow-Up The primary outcome was the rate of complete stone clearance. Patients were monitored throughout hospitalization and followed at 2 weeks, 1 month, and 3 months after discharge. Follow-up evaluations included clinical examinations, laboratory testing (e.g., liver function, inflammatory markers), and repeat imaging studies. Complications were recorded in real time, and their severity was graded using established clinical criteria.
Statistical Analysis Plan The sample size was calculated to detect a 15% difference in stone clearance rates between the two groups, with 80% power and a two-sided alpha of 0.05. Statistical analysis was performed using SPSS software. Categorical variables were compared using the Chi-square test or Fisher's exact test, as appropriate. Continuous variables were assessed using Student's t-test or the Mann-Whitney U test, depending on the distribution. Statistical significance was defined as P \< 0.05.
Ethical Considerations This study was approved by the Institutional Review Board of the National Liver Institute (Approval No. 00659) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants or, when applicable, from their legal guardians.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 400 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →National Liver Institute, Egypt is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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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.
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.
A plastic stent was placed during the initial ERCP, with elective stone removal scheduled 8-12 weeks later.
Immediate ERCP for stone removal, utilizing conventional techniques such as basket, balloon, or mechanical lithotripsy as needed.
Rate of complete stone clearance
complete removal of all detectable stones from the common bile duct without the need for additional procedures
Time frame: One month
ERCP-related adverse events
The incidence of ERCP-related adverse events during hospitalization, the duration of the procedure, the length of hospital stay, the time from ERCP to discharge, the need for repeat ERCP procedures or alternative biliary interventions due to stone recurrence or complications, and the overall patient morbidity and mortality rates
Time frame: Three months
Plan to share: No — There is no plan to share IPD for this study due to ethical and regulatory considerations, as well as the absence of a data-sharing infrastructure at our institution.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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National Liver Institute, Egypt