Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures (Spy+IDUS)

April 16, 2024 updated by: Jong Ho Moon, Soonchunhyang University Hospital

The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Patients aged 19 to under 80
  2. Presence of nonicteric biliary stricture
  3. Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion Criteria:

  1. Bleeding tendency (INR > 1.5 or platelets < 50000 mm3)
  2. Contraindication to ERCP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nonicteric stricture cohort
Patients with nonicteric biliary stricture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic accuracy of SOC
Time Frame: From enrollment through study completion, an average of 1 year
sensitivity, specificity, and accuracy of SOC
From enrollment through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of IDUS
Time Frame: From enrollment through study completion, an average of 1 year
sensitivity, specificity, and accuracy of IDUS
From enrollment through study completion, an average of 1 year
Technical success of SOC
Time Frame: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
Successful observation of extrahepatic duct using SOC
From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
Technical success of IDUS
Time Frame: From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
Successful observation of extrahepatic duct using IDUS
From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
Adverse event
Time Frame: From enrollment through study completion, an average of 1 year
All adverse event according to the American Society of Gastrointestinal Endoscopy criteria
From enrollment through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2024

Primary Completion (Estimated)

December 25, 2025

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SpyIDUSForNonictericStricture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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