Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Asian Institute of Gastroenterology, India.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Asian Institute of Gastroenterology, India
Information provided by:
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01182831
First received: August 14, 2010
Last updated: August 27, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Procedure: percutaneous fluoro guided celiac plexus neurolysis Procedure: EUS guided neurolysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Asian Institute of Gastroenterology, India:
Primary Outcome Measures:
- immediate pain relief [ Time Frame: day of block to six months of follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: percutaneous fluoro guided celiac plexus neurolysis |
Procedure: percutaneous fluoro guided celiac plexus neurolysis
It is percutaneous injection of neurolytic agent in and around the celiac ganglion
|
| Active Comparator: EUS guided neurolysis |
Procedure: EUS guided neurolysis
It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- all patients with carcinoma pancreas
Exclusion Criteria:
- patients below 18 years of age and who have not given consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01182831
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182831
Locations
| India | |
| Asian Institute of Gastroenterology | Recruiting |
| Hyderabad, Andhra pradesh, India, 500034 | |
| Contact: Santosh darisetty, MD +914023378888 ext 413 sant_dari@yahoo.com | |
| Contact: srikar darisetty, MD +914023378888 srikar.darisetty@gmail.com | |
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
More Information
| Responsible Party: | Dr.Santosh Darisetty, Asian Institute of Gastroenterology |
| ClinicalTrials.gov Identifier: | NCT01182831 History of Changes |
| Other Study ID Numbers: | AIG-GIA-201001 |
| Study First Received: | August 14, 2010 |
| Last Updated: | August 27, 2010 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Asian Institute of Gastroenterology, India:
|
carcinoma pancreas percutaneous celiac plexus neurolysis endosonography guided celiac plexus neurolysis |
Additional relevant MeSH terms:
|
Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pancrelipase Pancreatin Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 23, 2016