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Intraoperative Coeliac Plexus Alcohol Neurolysis Along With Frey's Procedure for a Better Pain Relief

NCT02735330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-04-12

No results posted yet for this study

Summary

To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a single centre setting with a Randomized Controlled Trial.

Conditions

  • Chronic Calcific Pancreatitis

Interventions

PROCEDURE

celiac plexus neurolysis using absolute alcohol

celiac plexus blockade with 40 ml of diluted absolute alcohol(50%) 20 ml on either side of celiac axis in a 4 quadrant fashion

PROCEDURE

Placebo celiac plexus injection using saline

Placebo celiac plexus injection with 40 ml of saline 20 ml on either side of celiac axis in a 4 quadrant fashion for blinding

PROCEDURE

Frey's procedure

Pancreatic head is partially resected (cored) along with longitudinal opening of duct along its entire length with limit of excavation of the head in the plane of the posterior wall of the Wirsung's duct and duct of Santorini is opened in the uncinate process. All the tissue above the plane, including the duct of Santorini is excised. The reconstruction is done with covering with a loop of jejunum in Roux-en-Y fashion which continues with the main pancreatic duct in the pancreatic body and tail.

Sponsors & Collaborators

  • Madras Medical College

    lead OTHER_GOV

Principal Investigators

  • KANNAN DEVYGOUNDER, MS,MCh,FRCS · MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIA

  • BALAKUMARAN SATHYAMOORTHY · MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2019-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02735330 on ClinicalTrials.gov