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

NCT01275768 | Unknown Phase 1 DMC

• 1 other identifier: AIG-GI-201101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

radio-frequency ablation; Malignant jaundice

Outcome Measures

Primary Outcomes (1)

• Time to stent occlusion

  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

  12 months

Secondary Outcomes (1)

• Death

  12 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Control arm

PLACEBO COMPARATOR

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

Interventions

Endoscopic radio-frequency ablation PROCEDURE

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

Control arm; Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age more than 18 years
• Histologically/ Cytologically confirmed malignancy

You may not qualify if:

• Informed consent not obtained or withdrawn
• Extremely poor general condition not amenable for conscious sedation used for ERC
• Candidate suitable for surgical resection
• Klatskin type 4 tumor
• Previous biliary intervention such as plastic stent insertion for more than 1 month
• Any other contra-indication to ERC

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

D. Nageshwar Reddy

Hyderabad, Andhra Pradesh, 500 082, India

Location

Study Officials

• D. Nageshwar Reddy, DM

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 14, 2011

Record last verified: 2011-01

Locations

IN (1)