NCT05056506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

September 20, 2021

Last Update Submit

August 13, 2023

Conditions

Choledocholithiasis

Keywords

Endoscopic sphincterotomyEndoscopic papillary balloon dilationComplicationSafetyCholedocholithiasis

Outcome Measures

Primary Outcomes (1)

  • The incidence of complications

    The incidence of complications

    within 1 months after the procedure

Secondary Outcomes (4)

  • The success rate of 1st session treatment

    within 1 months after the procedure

  • The rate of mechanical lithotripsy

    within 1 months after the procedure

  • Total ercp times

    within 1 months after the procedure

  • Overall successful stone removal rate

    within 1 months after the procedure

Study Arms (2)

Endoscopic papillary large balloon dilation group

ACTIVE COMPARATOR

Endoscopic papillary large balloon dilation to extract bile duct stones

Procedure: EPLBD

Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group

EXPERIMENTAL

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

Procedure: ELPBD+ESD

Interventions

EPLBDPROCEDURE

Endoscopic papillary large balloon dilation for Choledocholithiasis

Endoscopic papillary large balloon dilation group
ELPBD+ESDPROCEDURE

Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis

Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • large bile duct stones (≥10 mm)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23324454BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • Xiaofeng Zhang

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Yang, Doctor

CONTACT

086-13454132186yjf-1976@163.com

Lei Lu

CONTACT

086-13758268293zacharylu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 24, 2021

Study Start

September 1, 2021

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)