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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776709
Recruitment Status : Withdrawn
First Posted : May 18, 2016
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
University of California, Los Angeles
H. Lee Moffitt Cancer Center and Research Institute
University of Utah
Ochsner Health System
Information provided by (Responsible Party):
Sri Komanduri, Northwestern University

Brief Summary:

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.


Condition or disease Intervention/treatment
Bile Duct Strictures Common Bile Duct Stones Procedure: ERCP with cholangioscopy

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry
Study Start Date : July 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Group/Cohort Intervention/treatment
Bile duct Stricture
Patients referred for the evaluation of indeterminate strictures.
Procedure: ERCP with cholangioscopy
Common bile duct Stones
Patients referred for the removal of difficult stones.
Procedure: ERCP with cholangioscopy



Primary Outcome Measures :
  1. Stone clearance rate [ Time Frame: 6 months ]
    % of complete removal of bile duct stones


Secondary Outcome Measures :
  1. Diagnostic accuracy for indeterminate bile duct strictures [ Time Frame: 6 months ]
    Correlation of pathology with surgical specimen or 6month f/u



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Formation of a multi-site prospective database of all patients referred for the evaluation of indeterminate strictures or removal of difficult stones.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776709


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80202
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Northwestern University
University of Colorado, Denver
University of California, Los Angeles
H. Lee Moffitt Cancer Center and Research Institute
University of Utah
Ochsner Health System
Additional Information:

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Responsible Party: Sri Komanduri, Director of Endoscopy, Northwestern University
ClinicalTrials.gov Identifier: NCT02776709    
Other Study ID Numbers: STU00201104
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical