NCT05056506

EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Jianfeng Yang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Choledocholithiasis

Interventions

Type	Name	Description
PROCEDURE	EPLBD	Endoscopic papillary large balloon dilation for Choledocholithiasis
PROCEDURE	ELPBD+ESD	Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2021-09-24
• Last updated: 2023-08-16

Locations

2 sites across 1 country: China