EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Study Overview
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Brief Summary
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Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.

Detailed Description
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ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.

Official Title
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A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: EPLBD
* Procedure: ELPBD+ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: large bile duct stones (≥10 mm) Exclusion Criteria: pregnancy refusal of written informed consent Patients with benign or malignant biliary stricture Contraindications to ERCP exist Complicated with acute pancreatitis or acute cholangitis Coagulation dysfunction，thrombocytopenia prior EST or EPBD Patients after gastrointestinal reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic papillary large balloon dilation group<br>Endoscopic papillary large balloon dilation to extract bile duct stones | Procedure: EPLBD<br>* Endoscopic papillary large balloon dilation for Choledocholithiasis<br>|
| Experimental: Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group<br>Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones | Procedure: ELPBD+ESD<br>* Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complications | The incidence of complications | within 1 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of 1st session treatment | The success rate of 1st session treatment | within 1 months after the procedure | 
| The rate of mechanical lithotripsy | The rate of mechanical lithotripsy | within 1 months after the procedure | 
| Total ercp times | Total ercp numbers | within 1 months after the procedure | 
| Overall successful stone removal rate | Overall successful stone removal rate | within 1 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complication, Safety, Choledocholithiasis, Endoscopic sphincterotomy, Endoscopic papillary balloon dilation