search
Back to results

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Withdrawn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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Disease focused on measuring Benign Biliary Stenosis, Laser Excision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 8, 2014
    Last Updated
    December 2, 2015
    Sponsor
    University of Florida
    Collaborators
    Spectranetics Corporation
    search

    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
    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.
    Results Reference
    background
    PubMed Identifier
    23001533
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23857116
    Citation
    Garcia-Cano J. Endoscopic management of benign biliary strictures. Curr Gastroenterol Rep. 2013 Aug;15(8):336. doi: 10.1007/s11894-013-0336-2.
    Results Reference
    background
    PubMed Identifier
    21869908
    Citation
    Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21342673
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21161660
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23043953
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12042997
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12718480
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21050774
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19995111
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2305083
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Endo-biliary Laser Excision of Biliary Stenoses

    We'll reach out to this number within 24 hrs