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

NCT02615210 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-11-30

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Tract Neoplasms

Interventions

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 Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to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.

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Geisinger Clinic

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Temple University

    lead OTHER

Principal Investigators

  • Jennifre L Maranki, M.D. · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02615210 on ClinicalTrials.gov