Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01182831
• Other study ID #: AIG-GIA-201001
• Status: Recruiting
• Phase: Phase 1
• First received: August 14, 2010
• Last updated: August 27, 2010
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: August 2010
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• all patients with carcinoma pancreas

Exclusion Criteria:

• patients below 18 years of age and who have not given consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• percutaneous fluoro guided celiac plexus neurolysis
It is percutaneous injection of neurolytic agent in and around the celiac ganglion
• EUS guided neurolysis
It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Andhra pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immediate pain relief		day of block to six months of follow-up	Yes