Endoscopic Therapy of Malignant Bile Duct Strictures

Mass General Brigham

Status

Terminated

Conditions

Obstruction of Biliary Tree

Biliary Tract Cancer

Biliary Tract Neoplasms

Treatments

Device: Radiofrequency ablation catheter (Habib EndoHBP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01543607

11-405

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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