Endo-biliary Laser Excision of Biliary Stenoses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Biliary Tract Disease, Bile Duct Obstruction

Intervention / Treatment
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* Device: Benign Biliary Stenosis, Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benign Biliary Stenosis, Laser<br>Subjects that undergo the experimental intervention, that being single use of a laser excision catheter. | Device: Benign Biliary Stenosis, Laser<br>* Single use of laser to attempt excision of biliary ductal tissue causing stenosis.<br>* Other names: Spectranetics CVX-300 Excimer Laser System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients free of post-interventional complications after use of the endo-biliary laser. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Biliary Stenosis, Laser Excision