Endoscopic Therapy of Malignant Bile Duct Strictures

Stopped early · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01543607

Run by

Massachusetts General Hospital

People needed

1

Starts

2012-02-01

Expected to finish

2014-02-01

Last updated by the study team

2017-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented malignant biliary obstruction requiring ERCP guided stenting

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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