NCT01543607

Endoscopic Therapy of Malignant Bile Duct Strictures

Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstruction of Biliary Tree
• Biliary Tract Cancer
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
DEVICE	Radiofrequency ablation catheter (Habib EndoHBP)	Catheter placement into bile duct

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-03-05
• Last updated: 2017-04-24
• Results posted: 2017-04-24

Locations

1 site across 1 country: United States