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
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Time to stent occlusion
Study Overview
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
Detailed Description
We assume that application of endobiliary RFA to the malignant stricture which results in considerable charring of the tumor would result in prolongation of Self-expandable metal Stent (SEMS) patency by decreasing tumor in-growth and overgrowth. It is further speculated that prolonged stent patency will improve the quality of life of these patients, prevent cholangitis and optimize chemotherapy. A further outcome may be an improvement in the survival.
The research questions which we intend to answer through this trial would be:
- Does application of prior endo-biliary radiofrequency affect patency of SEMS?
- What are the complications associated with the use of endo-biliary RFA?
- Does endo-biliary RFA with immediate placement of SEMS improve patient survival?
- Is there any improvement in the quality of life of the patient with the combined use of endo-biliary RFA and SEMS?
Study protocol:
The study design is a double blind, sham operated, randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
- •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
Outcomes
Primary Outcomes
Time to stent occlusion
Time Frame: 12 months
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 Outcomes
- Death(12 months)