Biliary Tract DiseaseNCT02118493
Endo-biliary Laser Excision of Biliary Stenoses
A study testing Benign Biliary Stenosis, Laser in people with Biliary Tract Disease and Bile Duct Obstruction, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Disease, Bile Duct Obstruction
- What is being tested?
- Benign Biliary Stenosis, Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Biliary Tract Disease, Bile Duct Obstruction
- Being tested
- Benign Biliary Stenosis, Laser
- Keywords
- Benign Biliary Stenosis, Laser Excision
- Medical subject headings
- Biliary Tract Diseases, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benign Biliary Stenosis, LaserDevice
Also called Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter, Spectranetics CVX-300 Excimer Laser System
Single use of laser to attempt excision of biliary ductal tissue causing stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Benign Biliary Stenosis, Laser | Experimental | Subjects that undergo the experimental intervention, that being single use of a laser excision catheter. Receives: Device: Benign Biliary Stenosis, Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 100 weeks
Secondary outcomes (2)
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.
Measured: up to 100 weeks
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
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startDec 2015
- Primary completionJul 2016 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: The protocol has been withdrawn for re-evaluation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Spectranetics Corporation
- Responsible party
- Sponsor
- Investigators
- Beau Toskich, MD, Principal investigator, University of Florida Dept of Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118493
- Sponsor's protocol ID
- IRB201400129
- Status last verified
- Dec 2015
- First submitted
- 8 Apr 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12391514Shimada 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.
PubMed 23001533Garcia-Cano J. Endoscopic management of benign biliary strictures. Curr Gastroenterol Rep. 2013 Aug;15(8):336. doi: 10.1007/s11894-013-0336-2.
PubMed 23857116Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.
PubMed 21869908Peng 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.
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.
PubMed 21342673Rimon 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.
PubMed 21161660Shammas 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.
PubMed 23043953Steinkamp 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.
PubMed 12042997Karaca 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.
PubMed 12718480Kuo 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.
PubMed 21050774Dave 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.
PubMed 19995111Dachman 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.
PubMed 2305083
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-biliary Laser Excision of Biliary Stenoses: Initial Experience and Feasibility
- ClinicalTrials.gov ID
- NCT02118493
- Acronym / sponsor ID
- IRB201400129
- Conditions
- Biliary Tract Disease, Bile Duct Obstruction
- Keywords
- Benign Biliary Stenosis, Laser Excision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The protocol has been withdrawn for re-evaluation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Spectranetics Corporation
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benign Biliary Stenosis, Laser | Experimental | Device: Benign Biliary Stenosis, LaserSubjects that undergo the experimental intervention, that being single use of a laser excision catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benign Biliary Stenosis, LaserAlso: Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter, Spectranetics CVX-300 Excimer Laser SystemSingle use of laser to attempt excision of biliary ductal tissue causing stenosis. | Device | Benign Biliary Stenosis, Laser |
Primary outcome
Number of patients free of post-interventional complications after use of the endo-biliary laser.
Time frame: up to 100 weeks
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.
2 secondary outcomes
Technical success of endo-biliary laser excision via cholangiographic imaging.
Time frame: up to 100 weeks
Number of patients able to have internal-external biliary drainage catheters removed after endo-biliary laser excision.
Time frame: up to 100 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 12391514Laasch 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.
- Background: PubMed 23001533Shimada 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.
- Background: PubMed 23857116Garcia-Cano J. Endoscopic management of benign biliary strictures. Curr Gastroenterol Rep. 2013 Aug;15(8):336. doi: 10.1007/s11894-013-0336-2.
- Background: PubMed 21869908Zarrabi A, Gross AJ. The evolution of lasers in urology. Ther Adv Urol. 2011 Apr;3(2):81-9. doi: 10.1177/1756287211400494.
- BackgroundPeng 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: PubMed 21342673Kow 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.
- Background: PubMed 21161660Rimon 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.
- Background: PubMed 23043953Shammas 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.
- Background: PubMed 12042997Steinkamp 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.
- Background: PubMed 12718480Karaca 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.
- Background: PubMed 21050774Kuo 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.
- Background: PubMed 19995111Dave 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beau Toskich, MD principal investigator
University of Florida Dept of Interventional Radiology
Questions about this trial
What is this clinical trial studying?
A study testing Benign Biliary Stenosis, Laser in people with Biliary Tract Disease and Bile Duct Obstruction, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients free of post-interventional complications after use of the endo-biliary laser. (time frame: up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118493, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.