Clinical trial NCT02776709: Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System (SpyGlass)
Official title: Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bile Duct Strictures
Common Bile Duct Stones
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: University of California, Los Angeles
name: H. Lee Moffitt Cancer Center and Research Institute
name: University of Utah
name: Ochsner Health System
First posted: 2016-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Stone clearance rate
timeFrame: 6 months
Secondary outcomes:
measure: Diagnostic accuracy for indeterminate bile duct strictures
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: