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Endoscopic Therapy of Malignant Bile Duct Strictures

NCT01543607 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-04-24

Study results available
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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.

Conditions

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

Interventions

DEVICE

Radiofrequency ablation catheter (Habib EndoHBP)

Catheter placement into bile duct

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • William R Brugge, M.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543607 on ClinicalTrials.gov