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Completed

NCT Number: NCT03074201

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cholangioscopy

Procedure

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

Spyglass DS cholangioscope

Device

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

Primary outcomes

  1. Stone clearance

    Time frame: During the cholangioscopy procedure

    Successful clearance of stones from the bile duct using cholangioscopy

Secondary outcomes

  1. Procedure Duration

    Time frame: 5 minutes to 2.5 hours anticipated time frame

    Duration of procedure

Other outcomes

  1. Adverse Events

    Time frame: up to 30 weeks post-procedure

    Evaluation of adverse events following the procedure

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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