Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures (SOCABS)

November 27, 2023 updated by: Temple University
The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

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

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
  • Strictures located above the intrapancreatic bile duct
  • The Subject's physician determines and ERCP is clinically indicated
  • Able to provide informed consent

Exclusion Criteria:

  • Prior enrollment in the study or another study evaluating biliary strictures
  • Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
  • Pregnancy
  • At-risk populations including prisoners and mentally challenged
  • Unwilling to provide informed consent
  • Medically unfit to undergo ERCP
  • History of liver transplant

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard
Standard of care biopsies with optional SOC-directed biopsy afterwards
Experimental: Study
SOC-directed biopsies using the SpyGlass System plus standard of care biopsies
Device: SOC-directed biopsies using the SpyGlass System
The cholangioscopy procedure with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter positioned just below the operating channel of the duodenoscope. SpyBite Biopsy Forceps guided by the SpyScope Catheter are introduced and endoscopic-guided biopsy is taken at the level of the stricture. Target lesions will be identified under direct visualization using the SOC system, and 6-8 bites will be performed with the SpyBite forceps. Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to record potential adverse events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
Time Frame: 72 Hours
Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures
72 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis
Time Frame: 1 year
Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy
1 year
Endoscopic Satisfaction with SOC-directed biopsy
Time Frame: 2 hours

Endoscopist subjective outcomes using a Likert scale 1-5

  • Ease of obtaining the biopsies
  • Confidence that the biopsy was taken from the target lesion
  • Confidence that an adequate sample was obtained from the biopsy
  • Clinical impression of malignant disease
2 hours
Time from procedure to the initiation of treatment (in cases of malignancy)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Temple University

Collaborators

University of Pennsylvania
McGill University Health Centre/Research Institute of the McGill University Health Centre
Thomas Jefferson University
Geisinger Clinic
University of Pittsburgh Medical Center

Investigators

  • Principal Investigator: Jennifre L Maranki, M.D., Temple University

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)

November 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimated)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23154

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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