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

NCT02776709 | Withdrawn

• 1 other identifier: STU00201104
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Bile Duct Strictures; Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Stone clearance rate

  % of complete removal of bile duct stones

  6 months

Secondary Outcomes (1)

• Diagnostic accuracy for indeterminate bile duct strictures

  6 months

Study Arms (2)

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

Interventions

ERCP with cholangioscopy PROCEDURE

Bile duct Stricture; Common bile duct Stones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• All patients who are unable or unwilling to give consent will not be included in this study

Sponsors & Collaborators

• Northwestern University: lead
• University of Colorado, Denver: collaborator
• University of California, Los Angeles: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• University of Utah: collaborator
• Ochsner Health System: collaborator

Study Sites (5)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of Colorado, Denver

Denver, Colorado, 80202, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 18, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

US (5)