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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074201
• Other study ID #: 32194
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: May 20, 2017

Study information

• Verified date: September 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 20, 2017
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 and above

2. Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.

3. Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.

4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age <18

2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.

3. Participation in another related investigational study that could affect the results of this study within the previous 30 days

4. Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)

5. 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.)

5) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy

Related Conditions & MeSH terms

• Biliary Obstruction
• Choledocholithiasis

Intervention

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

Device:
• Spyglass DS Cholangioscope
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Evaluation of adverse events following the procedure	up to 30 weeks post-procedure
Primary	Stone clearance	Successful clearance of stones from the bile duct using cholangioscopy	During the cholangioscopy procedure
Secondary	Procedure Duration	Duration of procedure	5 minutes to 2.5 hours anticipated time frame