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Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System (SpyGlass)

NCT ID: NCT02776709

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-05-31

Brief Summary

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Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities.

The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.

Detailed Description

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All patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium. The PI or study coordinator will meet with the patient and discuss the study, its objectives, and obligations with each patient. After full disclosure, informed consent will be obtained.

Upon consent, basic demographics and data from prior procedures (when available) will be recorded. An endoscopist proficient in ERCP, with expertise in cholangioscopy, will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps (SpyBiteTM) and other accessories as necessary. Procedure time, visual findings, number of biopsies taken, pathology, stone location, stone size, and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database. All patients will be followed for 6-12 months or surgery (stricture cohort) to assess accuracy or stone recurrence rates.

Conditions

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Bile Duct Strictures Common Bile Duct Stones

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bile duct Stricture

Patients referred for the evaluation of indeterminate strictures.

ERCP with cholangioscopy

Intervention Type PROCEDURE

Common bile duct Stones

Patients referred for the removal of difficult stones.

ERCP with cholangioscopy

Intervention Type PROCEDURE

Interventions

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ERCP with cholangioscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients referred for the evaluation of indeterminate strictures or removal of difficult stones.

Exclusion Criteria

* All patients who are unable or unwilling to give consent will not be included in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Sri Komanduri

Director of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

University of Colorado, Denver

Denver, Colorado, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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STU00201104

Identifier Type: -

Identifier Source: org_study_id