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

NCT ID: NCT01182831

Last Updated: 2010-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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percutaneous fluoro guided celiac plexus neurolysis

Group Type ACTIVE_COMPARATOR

percutaneous fluoro guided celiac plexus neurolysis

Intervention Type PROCEDURE

It is percutaneous injection of neurolytic agent in and around the celiac ganglion

EUS guided neurolysis

Group Type ACTIVE_COMPARATOR

EUS guided neurolysis

Intervention Type PROCEDURE

It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.

Interventions

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percutaneous fluoro guided celiac plexus neurolysis

It is percutaneous injection of neurolytic agent in and around the celiac ganglion

Intervention Type PROCEDURE

EUS guided neurolysis

It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patients with carcinoma pancreas

Exclusion Criteria

* patients below 18 years of age and who have not given consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

Responsible Party

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Asian Institute of Gastroenterology

Locations

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Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Santosh darisetty, MD

Role: primary

+914023378888 ext. 413

srikar darisetty, MD

Role: backup

+914023378888

Other Identifiers

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AIG-GIA-201001

Identifier Type: -

Identifier Source: org_study_id

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