Endoscopic Therapy of Malignant Bile Duct Strictures

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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

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Obstruction of Biliary Tree Biliary Tract Cancer Biliary Tract Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Radiofrequency ablation catheter

Group Type EXPERIMENTAL

Radiofrequency ablation catheter (Habib EndoHBP)

Intervention Type DEVICE

Catheter placement into bile duct

Interventions

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Radiofrequency ablation catheter (Habib EndoHBP)

Catheter placement into bile duct

Intervention Type DEVICE

Other Intervention Names

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Habib EndoHBP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No