Clinical trial NCT01543607: Endoscopic Therapy of Malignant Bile Duct Strictures
Official title: Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstruction of Biliary Tree
Biliary Tract Cancer
Biliary Tract Neoplasms
Keywords: Bile duct
Cholangiocarcinoma
Bile duct stenosis
Malignant bile duct obstruction
Malignant bile duct stricture
Radiofrequency ablation
RFA
Endoscopic RFA catheter
EndoHPB
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Safety: Number of Bile Leak After RFA Procedure
timeFrame: 2 years
Secondary outcomes:
measure: Feasibility: Ease of the Radiofrequency Ablation Catheter Placement
timeFrame: 2 years
measure: Effectiveness: Change From Baseline in Bile Duct Diameter.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: William R Brugge, M.D.
role: PRINCIPAL_INVESTIGATOR
References: