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

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Unknown status

CT.gov ID

NCT01182831

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Procedure: percutaneous fluoro guided celiac plexus neurolysis Procedure: EUS guided neurolysis	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2011

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

immediate pain relief [day of block to six months of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients with carcinoma pancreas

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asian Institute of Gastroenterology	Hyderabad	Andhra pradesh	India	500034

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01182831

Other Study ID Numbers:

AIG-GIA-201001

First Posted:

Aug 17, 2010

Last Update Posted:

Aug 30, 2010

Last Verified:

Aug 1, 2010

Keywords provided by , ,

carcinoma pancreas

percutaneous celiac plexus neurolysis

endosonography guided celiac plexus neurolysis

Additional relevant MeSH terms:

Carcinoma

Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 30, 2010