Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP

NCT03074201 | Completed FDA Device

• 1 other identifier: 32194
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.

Conditions

Choledocholithiasis; Biliary Obstruction

Keywords

ERCP, choledocholithiasis, cholangioscopy

Outcome Measures

Primary Outcomes (1)

• Stone clearance

  Successful clearance of stones from the bile duct using cholangioscopy

  During the cholangioscopy procedure

Secondary Outcomes (1)

• Procedure Duration

  5 minutes to 2.5 hours anticipated time frame

Other Outcomes (1)

• Adverse Events

  up to 30 weeks post-procedure

Study Arms (1)

Cholangioscopy

EXPERIMENTAL

Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy

Procedure: Cholangioscopy; Device: Spyglass DS Cholangioscope

Interventions

Cholangioscopy PROCEDURE

Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.

Cholangioscopy

Spyglass DS Cholangioscope DEVICE

Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.

Cholangioscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
• Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if:

• Age \<18
• Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
• Participation in another related investigational study that could affect the results of this study within the previous 30 days
• Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
• Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)
• \) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy

Sponsors & Collaborators

• Stanford University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7.

  PMID: 28797911 DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 8, 2017
• Study Start: October 1, 2015
• Primary Completion: May 20, 2017
• Study Completion: May 20, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)