Back to resultsTrial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
percutaneous fluoro guided celiac plexus neurolysis
EUS guided neurolysis
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring carcinoma pancreas, percutaneous celiac plexus neurolysis, endosonography guided celiac plexus neurolysis
Eligibility Criteria
Inclusion Criteria:
- all patients with carcinoma pancreas
Exclusion Criteria:
- patients below 18 years of age and who have not given consent
Sites / Locations
- Asian Institute of GastroenterologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
percutaneous fluoro guided celiac plexus neurolysis
EUS guided neurolysis
Arm Description
Outcomes
Primary Outcome Measures
immediate pain relief
Secondary Outcome Measures
Full Information
NCT ID
NCT01182831
First Posted
August 14, 2010
Last Updated
August 27, 2010
Sponsor
Asian Institute of Gastroenterology, India
1. Study Identification
Unique Protocol Identification Number
NCT01182831
Brief Title
Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
Official Title
A Randomized Trial Comparing Fluoroscopy Guided Percutaneous Technique Versus Endoscopic Ultrasound Guided Technique of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 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
Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. There are limited data comparing the two modalities.The patients are on follow-up for 6 months post neurolysis.
Detailed Description
Carcinoma pancreas patients with abdominal pain requiring daily analgesics for more than 4 weeks were included.we are randomising about 100 patients into two groups to undergo either of the two procedures, i.e. celiac plexus neurolysis by percutaneous technique or by endoscopic ultrasound guided technique.The pain scores have been recorded by visual analogue scale for an average follow-up of 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
carcinoma pancreas, percutaneous celiac plexus neurolysis, endosonography guided celiac plexus neurolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
percutaneous fluoro guided celiac plexus neurolysis
Arm Type
Active Comparator
Arm Title
EUS guided neurolysis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
percutaneous fluoro guided celiac plexus neurolysis
Intervention Description
It is percutaneous injection of neurolytic agent in and around the celiac ganglion
Intervention Type
Procedure
Intervention Name(s)
EUS guided neurolysis
Intervention Description
It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.
Primary Outcome Measure Information:
Title
immediate pain relief
Time Frame
day of block to six months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with carcinoma pancreas
Exclusion Criteria:
patients below 18 years of age and who have not given consent
Facility Information:
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Andhra pradesh
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh darisetty, MD
Phone
+914023378888
Ext
413
Email
sant_dari@yahoo.com
First Name & Middle Initial & Last Name & Degree
srikar darisetty, MD
Phone
+914023378888
Email
srikar.darisetty@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
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