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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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