Endo-biliary Laser Excision of Biliary Stenoses
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/28/2015 |
| Start Date: | June 2015 |
| End Date: | May 2017 |
| Contact: | Beau Toskich, MD |
| Email: | toskib@radiology.ufl.edu |
| Phone: | 352-265-0291 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
