NCT06369896

Brief Summary

This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started May 2024

Typical duration for all trials

Status
not yet recruiting

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

Study Progress76%
May 2024Dec 2026

First Submitted

Initial submission to the registry

January 21, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Expected
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

January 21, 2024

Last Update Submit

April 16, 2024

Conditions

CholangiocarcinomaBiliary Stricture

Keywords

intraductal ultrasounddigital single-operator cholangioscopyindeterminate biliary stricture

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy of SOC

    sensitivity, specificity, and accuracy of SOC

    From enrollment through study completion, an average of 1 year

Secondary Outcomes (4)

  • Diagnostic accuracy of IDUS

    From enrollment through study completion, an average of 1 year

  • Technical success of SOC

    From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed

  • Technical success of IDUS

    From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed

  • Adverse event

    From enrollment through study completion, an average of 1 year

Study Arms (1)

Nonicteric stricture cohort

Patients with nonicteric biliary stricture

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indeterminate nonicteric (Bilirubin \< 2mg/dL) biliary stricture

You may qualify if:

  • Patients aged 19 to under 80
  • Presence of nonicteric biliary stricture
  • Previous endoscopic sphincterotomy or papillary balloon dilatation

You may not qualify if:

  • Bleeding tendency (INR \> 1.5 or platelets \< 50000 mm3)
  • Contraindication to ERCP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Jong Ho Moon, Dr.

CONTACT

800-324-2246jhmoonsch@gmail.com

Il Sang Shin, Dr.

CONTACT

800-324-2246110554@schmc.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jong Ho Moon

Study Record Dates

First Submitted

January 21, 2024

First Posted

April 17, 2024

Study Start

May 5, 2024

Primary Completion

December 25, 2025

Study Completion (Estimated)

December 25, 2026

Last Updated

April 17, 2024

Record last verified: 2024-04