EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

August 13, 2023 updated by: Jianfeng Yang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jianfeng Yang, Doctor
  • Phone Number: 086-13454132186
  • Email: yjf-1976@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Fourth People's Hospital
        • Contact:
          • Zhou Min
          • Phone Number: 13564878508
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31006
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
        • Contact:
          • Yang Wang, M.S
          • Phone Number: +86-0571-56006996
          • Email: wy8124@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endoscopic papillary large balloon dilation group
Endoscopic papillary large balloon dilation to extract bile duct stones
Procedure: EPLBD
Endoscopic papillary large balloon dilation for Choledocholithiasis
Experimental: Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group
Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones
Procedure: ELPBD+ESD
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of complications
Time Frame: within 1 months after the procedure
The incidence of complications
within 1 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of 1st session treatment
Time Frame: within 1 months after the procedure
The success rate of 1st session treatment
within 1 months after the procedure
The rate of mechanical lithotripsy
Time Frame: within 1 months after the procedure
The rate of mechanical lithotripsy
within 1 months after the procedure
Total ercp times
Time Frame: within 1 months after the procedure
Total ercp numbers
within 1 months after the procedure
Overall successful stone removal rate
Time Frame: within 1 months after the procedure
Overall successful stone removal rate
within 1 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianfeng Yang

Collaborators

First Affiliated Hospital of Zhejiang University
Second Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The Second Affiliated Hospital of Jiaxing University
Shanghai Fourth People's Hospital, School of Medicine, Tongji University

Investigators

  • Principal Investigator: Xiaofeng Zhang, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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