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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-05-20

Brief Summary

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

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Detailed Description

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Conditions

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Choledocholithiasis Biliary Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Cholangioscopy

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

Group Type EXPERIMENTAL

Cholangioscopy

Intervention Type PROCEDURE

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

Spyglass DS Cholangioscope

Intervention Type DEVICE

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

Interventions

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Cholangioscopy

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

Intervention Type PROCEDURE

Spyglass DS Cholangioscope

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No