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

Sponsor

Northwestern University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02776709

Collaborator

University of Colorado, Denver (Other), University of California, Los Angeles (Other), H. Lee Moffitt Cancer Center and Research Institute (Other), University of Utah (Other), Ochsner Health System (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Stone clearance rate [6 months]
% of complete removal of bile duct stones

Secondary Outcome Measures

Diagnostic accuracy for indeterminate bile duct strictures [6 months]
Correlation of pathology with surgical specimen or 6month f/u

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90095
2	University of Colorado, Denver	Denver	Colorado	United States	80202
3	Moffitt Cancer Center	Tampa	Florida	United States	33612
4	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
5	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sri Komanduri, Director of Endoscopy, Northwestern University

ClinicalTrials.gov Identifier:

NCT02776709

Other Study ID Numbers:

STU00201104

First Posted:

May 18, 2016

Last Update Posted:

Dec 4, 2020

Last Verified:

Dec 1, 2020

Additional relevant MeSH terms:

Constriction, Pathologic

Study Results

No Results Posted as of Dec 4, 2020