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

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ClinicalTrials.gov Identifier: NCT01182831
Recruitment Status : Unknown
Verified August 2010 by Asian Institute of Gastroenterology, India.
Recruitment status was:  Recruiting
First Posted : August 17, 2010
Last Update Posted : August 30, 2010
Sponsor:
Information provided by:
Asian Institute of Gastroenterology, India

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. immediate pain relief [ Time Frame: day of block to six months of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 2010

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