EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Last updated: August 13, 2023
Sponsor: Jianfeng Yang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Treatment

ELPBD+ESD

EPLBD

Clinical Study ID

NCT05056506
2021-02-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • large bile duct stones (≥10 mm)

Exclusion

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

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: ELPBD+ESD
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
October 30, 2023

Study 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.

Connect with a study center

  • Shanghai Fourth People's Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 31006
    China

    Active - Recruiting

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