Clinical trial NCT02118493: Endo-biliary Laser Excision of Biliary Stenoses
Official title: Endo-biliary Laser Excision of Biliary Stenoses: Initial Experience and Feasibility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Biliary Tract Disease
Bile Duct Obstruction
Keywords: Benign Biliary Stenosis
Laser Excision
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Spectranetics Corporation
First posted: 2014-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients free of post-interventional complications after use of the endo-biliary laser.
timeFrame: up to 100 weeks
Secondary outcomes:
measure: Technical success of endo-biliary laser excision via cholangiographic imaging.
timeFrame: up to 100 weeks
measure: Number of patients able to have internal-external biliary drainage catheters removed after endo-biliary laser excision.
timeFrame: up to 100 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida Dept of Interventional Radiology
name: Beau Toskich, MD
role: PRINCIPAL_INVESTIGATOR
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