Endo-biliary Laser Excision of Biliary Stenoses
Primary Purpose
Biliary Tract Disease, Bile Duct Obstruction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Benign Biliary Stenosis, Laser
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Disease focused on measuring Benign Biliary Stenosis, 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Benign Biliary Stenosis, Laser
Arm Description
Subjects that undergo the experimental intervention, that being single use of a laser excision catheter.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT02118493
First Posted
April 8, 2014
Last Updated
December 2, 2015
Sponsor
University of Florida
Collaborators
Spectranetics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02118493
Brief Title
Endo-biliary Laser Excision of Biliary Stenoses
Official Title
Endo-biliary Laser Excision of Biliary Stenoses: Initial Experience and Feasibility
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The protocol has been withdrawn for re-evaluation.
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Spectranetics Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Disease, Bile Duct Obstruction
Keywords
Benign Biliary Stenosis, Laser Excision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Benign Biliary Stenosis, Laser
Arm Type
Experimental
Arm Description
Subjects that undergo the experimental intervention, that being single use of a laser excision catheter.
Intervention Type
Device
Intervention Name(s)
Benign Biliary Stenosis, Laser
Other Intervention Name(s)
Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter, Spectranetics CVX-300 Excimer Laser System
Intervention Description
Single use of laser to attempt excision of biliary ductal tissue causing stenosis.
Primary Outcome Measure Information:
Title
Number of patients free of post-interventional complications after use of the endo-biliary laser.
Description
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.
Time Frame
up to 100 weeks
Secondary Outcome Measure Information:
Title
Technical success of endo-biliary laser excision via cholangiographic imaging.
Description
Intraprocedural ability to excise fibrotic biliary tissue with the laser will be assessed by comparing pre- and immediately post-cholangiographic imaging.
Time Frame
up to 100 weeks
Title
Number of patients able to have internal-external biliary drainage catheters removed after endo-biliary laser excision.
Description
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
Time Frame
up to 100 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beau Toskich, MD
Organizational Affiliation
University of Florida Dept of Interventional Radiology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12391514
Citation
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Endo-biliary Laser Excision of Biliary Stenoses
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