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

February 15, 2012
February 14, 2014
February 2012
February 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01543607 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Endoscopic Therapy of Malignant Bile Duct Strictures
Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstruction of Biliary Tree
  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
Device: Radiofrequency ablation catheter (Habib EndoHBP)
Catheter placement into bile duct
Other Name: Habib EndoHBP
Experimental: Treatment
Radiofrequency ablation catheter
Intervention: Device: Radiofrequency ablation catheter (Habib EndoHBP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01543607
11-405
Yes
William R. Brugge, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: William R Brugge, M.D. Massachusetts General Hospital
Massachusetts General Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP