A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 168
- Locations
- 2
- Primary Endpoint
- The incidence of complications
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The incidence of complications
Time Frame: within 1 months after the procedure
The incidence of complications
Secondary Outcomes
- The success rate of 1st session treatment(within 1 months after the procedure)
- The rate of mechanical lithotripsy(within 1 months after the procedure)
- Total ercp times(within 1 months after the procedure)
- Overall successful stone removal rate(within 1 months after the procedure)
Investigators
Jianfeng Yang
Professor
First People's Hospital of Hangzhou