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Endoscopic Therapy of Malignant Bile Duct Strictures

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ClinicalTrials.gov Identifier: NCT01543607
Recruitment Status : Terminated (Lack of enrollment)
First Posted : March 5, 2012
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital

Brief Summary:
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.

Condition or disease Intervention/treatment Phase
Obstruction of Biliary Tree Biliary Tract Cancer Biliary Tract Neoplasms Device: Radiofrequency ablation catheter (Habib EndoHBP) Not Applicable

Detailed Description:
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
Actual Study Start Date : February 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Radiofrequency ablation catheter
Device: Radiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct
Other Name: Habib EndoHBP



Primary Outcome Measures :
  1. Safety: Number of Bile Leak After RFA Procedure [ Time Frame: 2 years ]
    Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)


Secondary Outcome Measures :
  1. Feasibility: Ease of the Radiofrequency Ablation Catheter Placement [ Time Frame: 2 years ]
    Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.

  2. Effectiveness: Change From Baseline in Bile Duct Diameter. [ Time Frame: 2 years ]
    Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented malignant biliary obstruction requiring ERCP guided stenting

Exclusion Criteria:

  • Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
  • Evidence of high-grade symptomatic duodenal obstruction
  • Poor performance status
  • Active suppurative cholangitis
  • Complex stenoses will not be eligible for the trial
  • Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
  • Candidates for a Whipple resection
  • Patients who do not speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543607


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: William R Brugge, M.D. Massachusetts General Hospital

Additional Information:
Responsible Party: William R. Brugge, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01543607     History of Changes
Other Study ID Numbers: 11-405
First Posted: March 5, 2012    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: March 2017

Keywords provided by William R. Brugge, MD, Massachusetts General Hospital:
Bile duct
Cholangiocarcinoma
Bile duct stenosis
Malignant bile duct obstruction
Malignant bile duct stricture
Radiofrequency ablation
RFA
Endoscopic RFA catheter
EndoHPB

Additional relevant MeSH terms:
Constriction, Pathologic
Biliary Tract Neoplasms
Cholestasis
Pathological Conditions, Anatomical
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Bile Duct Diseases