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Recruitment Status : Withdrawn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
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|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|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|
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
- Stone clearance rate [ Time Frame: 6 months ]% of complete removal of bile duct stones
- Diagnostic accuracy for indeterminate bile duct strictures [ Time Frame: 6 months ]Correlation of pathology with surgical specimen or 6month f/u
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
|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|