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Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstructive Jaundice

NCT01275768 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-01-14

No results posted yet for this study

Summary

Patients with malignant obstructive jaundice (cancer of head of pancreas and cholangiocarcinoma) generally have a very poor prognosis with less than 20% patients having resectable disease at presentation. These patients also have a very poor quality of life with a life expectancy of 6-8 months. Jaundice associated with pruritus, poor appetite, malabsorption and loss of weight and cholangitis is the most common and troublesome problem. Placement of metallic stents has been the standard of care for patients with unresectable disease. However, about 50% of these stents get blocked in 6-8 months. Use of endoscopic Radio-frequency Ablation (RFA) prior to placement of metal stents may increase the patency of these stents

Conditions

  • Jaundice Extrahepatic Obstructive
  • Disorder of Bile Duct Stent

Interventions

PROCEDURE

Endoscopic radio-frequency ablation

Endobiliary radiofrequency catheter is 8Fr in diameter and can easily be passed over a 0.035 guide wire through the biopsy channel of a duodenoscope at the time of endoscopic retrograde cholangiography (ERC). Its use in the biliary system was heralded by animal experiments following which power settings of 7-10 Watts for 2 minutes were found to provide adequate ablation. The ablation results in charring of the tumor and this is expected to enhance the patency of SEMS

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • D. Nageshwar Reddy, DM · Asian Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • India

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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 NCT01275768 on ClinicalTrials.gov