EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Jianfeng Yang

Status: Enrolling

Conditions: Choledocholithiasis

Treatments: Procedure: EPLBD; Procedure: ELPBD+ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT05056506

2021-02-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

Endoscopic papillary large balloon dilation group

Active Comparator group

Description:

Endoscopic papillary large balloon dilation to extract bile duct stones

Treatment:

Procedure: EPLBD

Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group

Experimental group

Description:

Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones

Treatment:

Procedure: ELPBD+ESD