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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01275768
First received: January 11, 2011
Last updated: January 13, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Jaundice Extrahepatic Obstructive
Disorder of Bile Duct Stent
 Procedure: Endoscopic radio-frequency ablation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Controlled Prospective Trial of Endo-biliary Radio-frequency Ablation for Maintenance of Metal Stent Patency in Patients With Malignant Obstructive Jaundice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Time to stent occlusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Defined by a. Cholangitis b. or serum bilirubin > 3mg/dL with a previously normal bilirubin or above the baseline.

    c. Any clinical jaundice should be confirmed as being caused by stent occlusion by imaging or ERC



Secondary Outcome Measures:
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental arm
Insertion and activation of the endo-biliary RF catheter at the site of the stricture before insertion of a Self-expandable Metal Stent (SEMS)
 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
Placebo Comparator: Control arm
Insertion and sham activation of the endo-biliary RF catheter at the site of the stricture before insertion of a SEMS
 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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients: Clinical data and investigations suggestive of unresectable malignant bile duct obstruction. All patients will be discussed at the hepato-biliary multidisciplinary meeting which should come to a unanimous decision on tumor unresectability.
  2. Age more than 18 years
  3. Histologically/ Cytologically confirmed malignancy
  4. Informed consent: The patient should voluntarily agree to participation and randomization. Oral and written information about the nature of the trial will be given to all patients considered for inclusion.

Exclusion Criteria:

  1. Informed consent not obtained or withdrawn
  2. Extremely poor general condition not amenable for conscious sedation used for ERC
  3. Candidate suitable for surgical resection
  4. Klatskin type 4 tumor
  5. Previous biliary intervention such as plastic stent insertion for more than 1 month
  6. Any other contra-indication to ERC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275768

Locations
India
D. Nageshwar Reddy
Hyderabad, Andhra Pradesh, India, 500 082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Study Director: D. Nageshwar Reddy, DM Asian Institute of Gastroenterology
  More Information

No publications provided

Responsible Party: Dr. D. Nageshwar Reddy, Chairman, Asian Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT01275768     History of Changes
Other Study ID Numbers: AIG-GI-201101
Study First Received: January 11, 2011
Last Updated: January 13, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
radio-frequency ablation
Malignant jaundice

Additional relevant MeSH terms:
Bile Duct Diseases
Jaundice
Jaundice, Obstructive
Biliary Tract Diseases
Digestive System Diseases
 Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 18, 2012