Endoscopic Therapy of Malignant Bile Duct Strictures

Not Applicable

Terminated

Conditions: Biliary Tract Neoplasms
Obstruction of Biliary Tree
Biliary Tract Cancer

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Treatment	Radiofrequency ablation catheter (Habib EndoHBP)	Radiofrequency ablation catheter

Primary Outcome Measures

Name	Time	Method
Safety: Number of Bile Leak After RFA Procedure	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

Name	Time	Method
Effectiveness: Change From Baseline in Bile Duct Diameter.	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.
Feasibility: Ease of the Radiofrequency Ablation Catheter Placement	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.