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EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Primary Purpose

Choledocholithiasis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EPLBD
ELPBD+ESD
Sponsored by
Jianfeng Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety, Choledocholithiasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Fourth People's HospitalRecruiting
  • Hangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endoscopic papillary large balloon dilation group

Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group

Arm Description

Endoscopic papillary large balloon dilation to extract bile duct stones

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

Outcomes

Primary Outcome Measures

The incidence of complications
The incidence of complications

Secondary Outcome Measures

The success rate of 1st session treatment
The success rate of 1st session treatment
The rate of mechanical lithotripsy
The rate of mechanical lithotripsy
Total ercp times
Total ercp numbers
Overall successful stone removal rate
Overall successful stone removal rate

Full Information

First Posted
September 20, 2021
Last Updated
August 13, 2023
Sponsor
Jianfeng Yang
Collaborators
First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shanghai Fourth People's Hospital, School of Medicine, Tongji University
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1. Study Identification

Unique Protocol Identification Number
NCT05056506
Brief Title
EPLBD With Limited EST vs. EPLBD for Choledocholithiasis
Official Title
A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianfeng Yang
Collaborators
First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shanghai Fourth People's Hospital, School of Medicine, Tongji University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis
Keywords
Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety, Choledocholithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic papillary large balloon dilation group
Arm Type
Active Comparator
Arm Description
Endoscopic papillary large balloon dilation to extract bile duct stones
Arm Title
Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group
Arm Type
Experimental
Arm Description
Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones
Intervention Type
Procedure
Intervention Name(s)
EPLBD
Intervention Description
Endoscopic papillary large balloon dilation for Choledocholithiasis
Intervention Type
Procedure
Intervention Name(s)
ELPBD+ESD
Intervention Description
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis
Primary Outcome Measure Information:
Title
The incidence of complications
Description
The incidence of complications
Time Frame
within 1 months after the procedure
Secondary Outcome Measure Information:
Title
The success rate of 1st session treatment
Description
The success rate of 1st session treatment
Time Frame
within 1 months after the procedure
Title
The rate of mechanical lithotripsy
Description
The rate of mechanical lithotripsy
Time Frame
within 1 months after the procedure
Title
Total ercp times
Description
Total ercp numbers
Time Frame
within 1 months after the procedure
Title
Overall successful stone removal rate
Description
Overall successful stone removal rate
Time Frame
within 1 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Yang, Doctor
Phone
086-13454132186
Email
yjf-1976@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Lu
Phone
086-13758268293
Email
zacharylu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Min
Phone
13564878508
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang, M.D
Phone
+86-0571-56006999
Email
yjf-1976@163.com
First Name & Middle Initial & Last Name & Degree
Yang Wang, M.S
Phone
+86-0571-56006996
Email
wy8124@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23324454
Citation
Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013 Jan 17;13:15. doi: 10.1186/1471-230X-13-15.
Results Reference
background

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EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

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