Endoscopic Therapy of Malignant Bile Duct Strictures

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01543607
First received: February 15, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 catheter is in patient with malignant bile duct stenosis.


Condition Intervention
Obstruction of Biliary Tree
Biliary Tract Cancer
Biliary Tract Neoplasms
Device: Radiofrequency ablation catheter (Habib EndoHBP)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety: Number of bile leak after RFA procedure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)


Secondary Outcome Measures:
  • Feasibility: Ease of the radiofrequency Ablation Catheter Placement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Effectiveness: Change from Baseline in bile duct diameter. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure.


Estimated Enrollment: 10
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Radiofrequency ablation catheter
Device: Radiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct
Other Name: Habib EndoHBP

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: William R. Brugge, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01543607     History of Changes
Other Study ID Numbers: 11-405
Study First Received: February 15, 2012
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Biliary Tract Neoplasms
Neoplasms
Cholestasis
Constriction, Pathologic
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Bile Duct Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014