NCT02118493

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

April 8, 2014

Last Update Submit

December 2, 2015

Conditions

Biliary Tract DiseaseBile Duct Obstruction

Keywords

Benign Biliary StenosisLaser Excision

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 100 weeks

Secondary Outcomes (2)

  • Technical success of endo-biliary laser excision via cholangiographic imaging.

    up to 100 weeks

  • Number of patients able to have internal-external biliary drainage catheters removed after endo-biliary laser excision.

    up to 100 weeks

Study Arms (1)

Benign Biliary Stenosis, Laser

EXPERIMENTAL

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

Device: Benign Biliary Stenosis, Laser

Interventions

Benign Biliary Stenosis, LaserDEVICE

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

Also known as: Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter, Spectranetics CVX-300 Excimer Laser System
Benign Biliary Stenosis, Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 12391514BACKGROUND

  • 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.

    PMID: 23001533BACKGROUND

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

    PMID: 23857116BACKGROUND

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

    PMID: 21869908BACKGROUND

  • 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.

    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.

    PMID: 21342673BACKGROUND

  • 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.

    PMID: 21161660BACKGROUND

  • 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.

    PMID: 23043953BACKGROUND

  • 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.

    PMID: 12042997BACKGROUND

  • 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.

    PMID: 12718480BACKGROUND

  • 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.

    PMID: 21050774BACKGROUND

  • 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.

    PMID: 19995111BACKGROUND

  • 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.

    PMID: 2305083BACKGROUND

MeSH Terms

Conditions

Biliary Tract DiseasesCholestasis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Digestive System DiseasesBile Duct Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Beau Toskich, MD

    University of Florida Dept of Interventional Radiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 21, 2014

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

May 1, 2017

Last Updated

December 3, 2015

Record last verified: 2015-12