Endoscopic Radiofrequency Ablation in Treating Patients With Malignant Biliary Obstruction
Basic Trial Information
|No phase specified||Supportive care, Treatment||Active||18 and over||11-405|
This pilot clinical trial studies endoscopic radiofrequency ablation in treating patients with malignant biliary obstruction. A radiofrequency ablation catheter (stent) is placed into the bile duct and heat is applied to the bile duct to open the blockage or obstruction. Radiofrequency ablation may reduce or prevent tissue re-growth into the stent and tumor ingrowth.
Further Study Information
I. Determination of safety as measured by the presence of a bile leaks (as defined by contrast cholangiography) as a result of radiofrequency ablation.
I. To determine the feasibility of radiofrequency ablation catheter placement across malignant strictures.
II. To determine effectiveness (change in stricture diameter as a result of radiofrequency ablation [RFA]).
Patients undergo RFA over 10 minutes.
After completion of study treatment, patients are followed up at 3 days.
Documented malignant biliary obstruction requiring endoscopic retrograde cholangiopancreatography (ERCP) guided stenting; documentation of malignancy will be made before the scheduled procedure and rapid pathology readings will not be used as a documentation of malignancy; documentation of malignancy may be in the form of;
Histology (bile duct biopsy)
Liver or pancreas fine needle aspiration (FNA), biliary
Cross sectional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) and abnormal liver function tests (findings compatible with obstruction)
Ability to understand and the willingness to sign a written informed consent document are required
International normalized ratio (INR) > 2.0
Or partial thromboplastin time [PTT] > 100 sec
Or platelet count < 50,000
Coagulopathy tests will be obtained within 2 weeks of enrollment
Patients with evidence of high-grade symptomatic duodenal obstruction
Poor performance status (Karnofsky score of less than 60)
Active suppurative cholangitis (hypotension, acidemia, mental status changes)
Complex stenoses (Bismuth grade IV) will not be eligible for the trial
Patients without access to the duodenum or ampulla are not candidates for ERCP and stenting
Candidates for a Whipple resection; candidates of the Whipple resection will be excluded based on the written recommendations by surgery, oncology, and/or the patient’s primary care physician
Patients who do not speak English; there is no direct medical benefit to the patients in this study and furthermore, it is critical that subjects understand the nature and risks of RFA
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Dana-Farber Harvard Cancer Center
- National Cancer Institute
Massachusetts General Hospital
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01543607
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.