NCT04242394

Brief Summary

This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,019

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2024

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

January 22, 2020

Last Update Submit

December 13, 2025

Conditions

Cholecystitis

Keywords

ERCPAcute purulent cholecystitisBile duct stonePost-ERCP-Choledocholithiasis PEC

Outcome Measures

Primary Outcomes (1)

  • Number of Acute PEC(post-ERCP-cholecystitis )

    When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade

    1month

Secondary Outcomes (3)

  • Number of Pancreatitis

    1month

  • Number of Cholangitis

    1 month

  • Number of Perforation

    1 month

Study Arms (2)

Chronic gallbladder diseases

Routine ERCP participants with chronic gallbladder diseases

Procedure: ERCP

Without Chronic gallbladder disease

Routine ERCP participants without chronic gallbladder diseases

Procedure: ERCP

Interventions

ERCPPROCEDURE

Routine ERCP procedures with gallbladder in situ patient

Chronic gallbladder diseasesWithout Chronic gallbladder disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Common bile duct stone ERCP patients with gallbladder in situ

You may qualify if:

  • ERCP patients with gallbladder in situ

You may not qualify if:

  • Acute cholecystitis before surgery
  • Gallbladder has been removed
  • Gastrointestinal reconstruction
  • Unwillingness or inability to consent for the study
  • Unstable vital signs Coagulation dysfunction (INR\>1.5)
  • Low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock Biliary- duodenal fistula confirmed during ERCP
  • Pregnant women or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chinese herb medicine hospital of Longnan City

Longnan, Gansu, 746000, China

Location

The first hospital of Tianshui

Tianshui, Gansu, 741000, China

Location

Wuwei turmour hospital

Wuwei, Gansu, 733000, China

Location

Related Publications (3)

  • Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/s12876-019-1053-6.

    PMID: 31382888BACKGROUND

  • Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3.

    PMID: 30134864BACKGROUND

  • Jin B, Wang Y, Zhang X, Zhao J, He W, Jin K, Liu Z, Zhong R, Ma Y, Dong C, Lin Y, Zhu X, Zhu K, Zhang L, Yue P, Li S, Yuan J, Li X, Meng W. Identifying high-risk patients having ERCP as a day surgery with an online prediction platform: Multicohort validation of a machine learning model. Endosc Int Open. 2025 Dec 16;13:a27331387. doi: 10.1055/a-2733-1387. eCollection 2025.

    PMID: 41567602DERIVED

MeSH Terms

Conditions

CholecystitisCholecystolithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Wenbo Meng, M.D., Ph. D.

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph. D, Direct of surgery

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

February 14, 2020

Primary Completion

November 16, 2024

Study Completion

November 16, 2024

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)