Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014