NCT05905744

Brief Summary

When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

May 31, 2023

Last Update Submit

June 14, 2023

Conditions

Bile Duct Stenosis

Outcome Measures

Primary Outcomes (2)

  • positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis

    The results are compared with pathological results of surgical specimens

    1 years

  • positive rate of cholangioscopy-guided forceps biopsy

    The results are compared with pathological results of surgical specimens

    1 years

Secondary Outcomes (2)

  • adverse event rate of each individual technique

    1 years

  • the positive rate of biopsy

    1 years

Study Arms (1)

patients with unexplained bile duct stenosis

Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP

Diagnostic Test: cholangioscopy

Interventions

cholangioscopyDIAGNOSTIC_TEST

cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP

patients with unexplained bile duct stenosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.

You may qualify if:

  • Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);

You may not qualify if:

  • Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;
  • Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yunfeng Wang, Doctor

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhendong Jin, Doctor

CONTACT

13901618837Zhendjin@126.com

Yunfeng Wang, Doctor

CONTACT

13651663501Fanhuiever@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 15, 2023

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

July 1, 2024

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share