EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Not Applicable

Recruiting

• Conditions: Choledocholithiasis
• Interventions: Procedure: ELPBD+ESD; Procedure: EPLBD

• Registration Number: NCT05056506
• Lead Sponsor: Jianfeng Yang

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-16
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group	ELPBD+ESD	Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones
Endoscopic papillary large balloon dilation group	EPLBD	Endoscopic papillary large balloon dilation to extract bile duct stones

Primary Outcome Measures

Name	Time	Method
The incidence of complications	within 1 months after the procedure	The incidence of complications

Secondary Outcome Measures

Name	Time	Method
The success rate of 1st session treatment	within 1 months after the procedure	The success rate of 1st session treatment
The rate of mechanical lithotripsy	within 1 months after the procedure	The rate of mechanical lithotripsy
Total ercp times	within 1 months after the procedure	Total ercp numbers
Overall successful stone removal rate	within 1 months after the procedure	Overall successful stone removal rate

Trial Locations

Locations (2)

Shanghai Fourth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China