MedDataX Logo

Endo-biliary Laser Excision of Biliary Stenoses

NCT ID: NCT02118493

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biliary Tract Disease Bile Duct Obstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Benign Biliary Stenosis, Laser

Subjects that undergo the experimental intervention, that being single use of a laser excision catheter.

Group Type EXPERIMENTAL

Benign Biliary Stenosis, Laser

Intervention Type DEVICE

Single use of laser to attempt excision of biliary ductal tissue causing stenosis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Benign Biliary Stenosis, Laser

Single use of laser to attempt excision of biliary ductal tissue causing stenosis.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter Spectranetics CVX-300 Excimer Laser System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Spectranetics Corporation

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beau Toskich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Dept of Interventional Radiology

References

Explore related publications, articles, or registry entries linked to this study.

Laasch HU, Martin DF. Management of benign biliary strictures. Cardiovasc Intervent Radiol. 2002 Nov-Dec;25(6):457-66. doi: 10.1007/s00270-002-1888-y. Epub 2002 Oct 24.

Reference Type BACKGROUND
PMID: 12391514 (View on PubMed)

Shimada H, Endo I, Shimada K, Matsuyama R, Kobayashi N, Kubota K. The current diagnosis and treatment of benign biliary stricture. Surg Today. 2012 Dec;42(12):1143-53. doi: 10.1007/s00595-012-0333-3. Epub 2012 Sep 22.

Reference Type BACKGROUND
PMID: 23001533 (View on PubMed)

Garcia-Cano J. Endoscopic management of benign biliary strictures. Curr Gastroenterol Rep. 2013 Aug;15(8):336. doi: 10.1007/s11894-013-0336-2.

Reference Type BACKGROUND
PMID: 23857116 (View on PubMed)

Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.

Reference Type BACKGROUND
PMID: 21869908 (View on PubMed)

Peng Q, Juzeniene A, Chen J, et al. Lasers in medicine. Reports Prog Phys. 2008;71(5):056701. doi:10.1088/0034-4885/71/5/056701.

Reference Type BACKGROUND

Kow AW, Wang B, Wong D, Sundeep PJ, Chan CY, Ho CK, Liau KH. Using percutaneous transhepatic cholangioscopic lithotripsy for intrahepatic calculus in hostile abdomen. Surgeon. 2011 Apr;9(2):88-94. doi: 10.1016/j.surge.2010.08.002.

Reference Type BACKGROUND
PMID: 21342673 (View on PubMed)

Rimon U, Kleinmann N, Bensaid P, Golan G, Garniek A, Khaitovich B, Winkler H. Percutaneous transhepatic endoscopic holmium laser lithotripsy for intrahepatic and choledochal biliary stones. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1262-6. doi: 10.1007/s00270-010-0058-x. Epub 2010 Dec 16.

Reference Type BACKGROUND
PMID: 21161660 (View on PubMed)

Shammas NW, Shammas GA, Hafez A, Kelly R, Reynolds E, Shammas AN. Safety and One-Year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center. Cardiovasc Revasc Med. 2012 Nov-Dec;13(6):341-4. doi: 10.1016/j.carrev.2012.08.012. Epub 2012 Oct 6.

Reference Type BACKGROUND
PMID: 23043953 (View on PubMed)

Steinkamp HJ, Wissgott C, Rademaker J, Scheinert D, Werk M, Settmacher U, Felix R. Short (1-10 cm) superficial femoral artery occlusions: results of treatment with excimer laser angioplasty. Cardiovasc Intervent Radiol. 2002 Sep-Oct;25(5):388-96. doi: 10.1007/s00270-002-1864-6. Epub 2002 Jun 4.

Reference Type BACKGROUND
PMID: 12042997 (View on PubMed)

Karaca I, Ilkay E, Akbulut M, Yavuzkir M. Treatment of in-stent restenosis with excimer laser coronary angioplasty. Jpn Heart J. 2003 Mar;44(2):179-86. doi: 10.1536/jhj.44.179.

Reference Type BACKGROUND
PMID: 12718480 (View on PubMed)

Kuo WT, Cupp JS. The excimer laser sheath technique for embedded inferior vena cava filter removal. J Vasc Interv Radiol. 2010 Dec;21(12):1896-9. doi: 10.1016/j.jvir.2010.08.013. Epub 2010 Nov 3.

Reference Type BACKGROUND
PMID: 21050774 (View on PubMed)

Dave RM, Patlola R, Kollmeyer K, Bunch F, Weinstock BS, Dippel E, Jaff MR, Popma J, Weissman N; CELLO Investigators. Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry. J Endovasc Ther. 2009 Dec;16(6):665-75. doi: 10.1583/09-2781.1.

Reference Type BACKGROUND
PMID: 19995111 (View on PubMed)

Dachman AH, McGehee JA, Beam TE, Venbrux AC, Hoyt RF, Burris JA. Animal model for fluoroscopically guided laser application in the biliary tree. Radiology. 1990 Mar;174(3 Pt 2):1021-5. doi: 10.1148/radiology.174.3.174-3-1021.

Reference Type BACKGROUND
PMID: 2305083 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB201400129

Identifier Type: -

Identifier Source: org_study_id