Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstructive Jaundice
Primary Purpose
Jaundice Extrahepatic Obstructive, Disorder of Bile Duct Stent
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Endoscopic radio-frequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Jaundice Extrahepatic Obstructive focused on measuring radio-frequency ablation, Malignant jaundice
Eligibility Criteria
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- Informed consent not obtained or withdrawn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
Sites / Locations
- D. Nageshwar Reddy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental arm
Control arm
Arm Description
Insertion and activation of the endo-biliary RF catheter at the site of the stricture before insertion of a Self-expandable Metal Stent (SEMS)
Insertion and sham activation of the endo-biliary RF catheter at the site of the stricture before insertion of a SEMS
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Death
Full Information
NCT ID
NCT01275768
First Posted
January 11, 2011
Last Updated
January 13, 2011
Sponsor
Asian Institute of Gastroenterology, India
1. Study Identification
Unique Protocol Identification Number
NCT01275768
Brief Title
Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstructive Jaundice
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Asian Institute of Gastroenterology, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 Endoscopic retrograde Cholangiography (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
Randomization:
After obtaining an informed consent and satisfying the inclusion criteria, the patients will be randomized to one of the following two arms using computer generated randomization blocks. The operator and the patient will be blinded to use of RFA
Experimental arm: Insertion and activation of the endo-biliary RF catheter at the site of the stricture before insertion of a SEMS
Control arm: Insertion and sham activation of the endo-biliary RF catheter at the site of the stricture before insertion of a SEMS.
All patients will get the same SEMS with variable lengths (depending on the stricture size) to maintain uniformity. Endoscopic sphincterotomy will be performed in all patients prior to endo-biliary RF application and SEMS insertion. Opacification of the cystic duct and whether the endo-biliary RFA catheter was placed at the cystic duct opening will be recorded.
Data Collection:
Baseline data will be collected by an advanced endoscopy fellow and will include age, gender, WHO performance score, presence of gall bladder or gall stones, primary tumor type and stage, baseline liver function test, adjuvant chemo/radiotherapy
After discharge from the hospital, the patients will be followed up in the clinic at 1 week, 1 month, 3 months, 6 months, 9 months and 12 months. At each visit, a detailed clinical history, examination, adverse events, adjuvant therapy and liver function tests will be carried out. Patients will be assessed according to the World Health Organization performance classification.
WHO score
0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
2 - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
3 - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
4 - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
5 - Death All patients will be referred for an oncological opinion for palliative chemotherapy. The patients and their care-givers will be told about symptoms of cholangitis and stent obstruction and will be asked to contact the hospital immediately in such cases. In the event of a confirmed SEMS occlusion, either a new SEMS or a plastic stent will be placed depending on the patient's prognosis.
End points:
Stent occlusion:
Cholangitis
or serum bilirubin > 3mg/dL with a previously normal bilirubin or above the baseline.
Any clinical jaundice should be confirmed as being caused by stent occlusion by imaging or ERC
Death
Uneventful follow-up for 12 months
Evaluation:
The primary aim will be to compare the two groups for duration of stent patency.
The secondary aims will be:
To study any complications attributable to endo-biliary RFA
To study if there is any improvement in patient survival
To study if there is any improvement in patient's quality of life
Statistics:
We assume that the metal stent patency will improve from 50% to 80% at 6-8 months. With a 80% power and alpha error of 5%, we will need 43 patients in each arm. The Fisher exact test will be used to evaluate any differences in the patient distribution. The Student unpaired t test will be used to compare the laboratory tests, age and sex. Cumulative stent patency and patient survival will be estimated using the Kaplan-Meier method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice Extrahepatic Obstructive, Disorder of Bile Duct Stent
Keywords
radio-frequency ablation, Malignant jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Insertion and activation of the endo-biliary RF catheter at the site of the stricture before insertion of a Self-expandable Metal Stent (SEMS)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Insertion and sham activation of the endo-biliary RF catheter at the site of the stricture before insertion of a SEMS
Intervention Type
Procedure
Intervention Name(s)
Endoscopic radio-frequency ablation
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to stent occlusion
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Death
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Nageshwar Reddy, DM
Organizational Affiliation
Asian Institute of Gastroenterology
Official's Role
Study Director
Facility Information:
Facility Name
D. Nageshwar Reddy
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
12. IPD Sharing Statement
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Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstructive Jaundice
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