Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

November 23, 2023 updated by: Jong Ho Moon, Soonchunhyang University Hospital

Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones

This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.

Study Type

Observational

Enrollment (Estimated)

236

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

  • Name: Jong Ho Moon, MD,PhD,FASGE,FJGES
  • Phone Number: +82-32-62-5094
  • Email: jhmoonsch@gmail.com

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
        • Recruiting
        • Soonchunhyang University Bucheon Hospital
        • Contact:
        • Contact:

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

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We plan to recruit a total of 239 patients, assuming that the detection rate of neoplastic bile duct is about 3.5% by referring to the preceding literature. (one-sample inference for binomial proportions, one-sided test, significance 5%, power 80%)

Description

Inclusion Criteria:

  1. Aged > 18 years
  2. Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
  3. Patients who undergo ERCP for confirmation of CBD clearance
  4. Dilated common bile duct (> 10 mm)
  5. Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation

Exclusion Criteria:

  1. Presence of biliary tract cancer
  2. Presence of distal CBD stricture
  3. Bleeding tendency (INR>1.5 or platelets <50000 mm3)
  4. Contraindications of 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DSOC group
Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy.
Procedure: Single-operator cholangioscopy
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate
Time Frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy
Until the end of the single-operator cholangioscopy session (up to 20 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of cholangioscopy
Time Frame: Up to 15 minutes from the time the endoscope passes through the oral cavity
successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree
Up to 15 minutes from the time the endoscope passes through the oral cavity
Technical success of cholangioscopy-guided biopsy
Time Frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
successful tissue sampling of intraductal superficial lesions under direct visualization
Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Adverse events
Time Frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria
From the start of endoscopy to the end of the study observation period (at least 12 months)
Number needed to screen
Time Frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients
From the start of endoscopy to the end of the study observation period (at least 12 months)

Collaborators and Investigators

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

Sponsor

Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 30, 2022

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • screeningsoc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

By sharing and conducting research, we try to share pain and optimize performance through cooperation. Details have not been decided yet.

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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