Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at UCLA
study started
estimated completion:
V. Raman Muthusamy (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Bile Duct Strictures Common Bile Duct Stones ERCP with cholangioscopy Bile duct Stricture

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States

Lead Scientist

  • V. Raman Muthusamy (ucla)
    Director, Interventional and General Endoscopy. Authored (or co-authored) 8 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT02776709
Study Type
Observational [Patient Registry]
Last Updated