Endo-biliary Laser Excision of Biliary Stenoses

December 2, 2015 updated by: University of Florida

Endo-biliary Laser Excision of Biliary Stenoses: Initial Experience and Feasibility

The biliary system normally empties into the intestines, however, some patients have biliary system narrow areas ("stenosis") that prevent the bile to drain normally. These may be related to an underlying disease or previous surgery. Patients with this problem usually require tubes to be inserted into the biliary system to drain bile into a bag outside of their body, impacting their quality of life.

The purpose of this research study is to use a laser device to try to re-open the biliary drainage system.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The current preferred minimally invasive treatment for surgically related or in-situ benign biliary stenosis (BBS) involves open surgical revision, endoscopic retrograde cholangiographic (ERCP) or percutaneous transhepatic cholangiographic (PTC) balloon angioplasty and/or stent/biliary catheter placement. Unfortunately, most patients are poor open surgical operative candidates. Although ERCP is the preferred secondary approach, anatomical restrictions often require PTC. Additionally, previously placed biliary stents/catheters have poor long term patency and require routine exchange every 3-6 months. The vast majority of surgically related BBS patients are non-operative candidates for surgical revision of their BBS, and do not have favorable anatomy for ERCP access. For patients who have failed aggressive PTC balloon angioplasty of their stenoses, treatment consists of indefinite biliary catheter exchanges every 3 months. Lifelong biliary catheter dependence severely impacts the quality of life in an otherwise healthy patient with no additional evidence of their initial disease process.

A potential long-term therapy to alleviate BBS that has not been explored is the use of laser excision of the fibrotic tissue responsible for these stenoses. Therapeutic applications of lasers in medicine is not a novel concept. Its use has been well documented in the urologic tract to ablate tissue (benign prostatic hypertrophy) and renal stones. Recent laser therapeutic use in the biliary tract to dissolve gallstones has been described. The laser excision of BBS has potential to provide long term alleviation of BBS. The primary endpoint of this feasibility study is to assess the safety and initial efficacy of BBS laser excision.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with diagnosed benign biliary stenosis
  • Initial total serum bilirubin > 1.9 mg/dL
  • Subjects currently having an internal/external percutaneous biliary drain
  • Subjects that have failed at least 3 separate biliary stenosis balloon angioplasties and are deemed non-surgical candidates by the transplant and/or pancreaticobiliary surgical services at the University of Florida

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benign Biliary Stenosis, Laser
Subjects that undergo the experimental intervention, that being single use of a laser excision catheter.
Device: Benign Biliary Stenosis, Laser
Single use of laser to attempt excision of biliary ductal tissue causing stenosis.
Other Names:
  • Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter
  • Spectranetics CVX-300 Excimer Laser System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients free of post-interventional complications after use of the endo-biliary laser.
Time Frame: up to 100 weeks
Patients will be assessed for safety after the endo-biliary laser use. Specifically, intraprocedural, immediate post-procedural (up to 4 hours), phone conversation 1 week post-procedure, and regularly scheduled 4 week post-procedure follow-up appointments will document the patient's tolerance of the procedure and any deviations from patients receiving biliary tube exchanges. Particular attention will be placed on regularly monitored signs/symptoms, such as cholangiographic appearance, total bilirubin, jaundice/fever/abdominal pain, etc. As each patient follows up on an ~4 week basis, any potential post-intervention complication will be documented.
up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of endo-biliary laser excision via cholangiographic imaging.
Time Frame: up to 100 weeks
Intraprocedural ability to excise fibrotic biliary tissue with the laser will be assessed by comparing pre- and immediately post-cholangiographic imaging.
up to 100 weeks
Number of patients able to have internal-external biliary drainage catheters removed after endo-biliary laser excision.
Time Frame: up to 100 weeks
Although this study is not powered to truly measure efficacy of this intervention, the investigators will monitor patient's for possible removal of required internal-external biliary drainage after the laser intervention. This will be monitored by 1) post-intervention follow-up cholangiograms 2) capping of the internal-external biliary drainage tube while monitoring patient symptoms and total bilirubin level and 3) possible removal of internal-external biliary tube post-intervention
up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Spectranetics Corporation

Investigators

  • Principal Investigator: Beau Toskich, MD, University of Florida Dept of Interventional Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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