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

NCT02735330 | Unknown DMC

• 2 other identifiers: ID-NO 23052015CTRI/2016/02/006593
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CCP

Outcome Measures

Primary Outcomes (1)

• Pain relief measured by Visual Analogue Scale

  Short term (2 years) and long term(5 years) score at follow up at out patient clinic or over phone.

  up to 5 years

Secondary Outcomes (7)

• Number of patients with improvement in endocrine function as measured by Fasting glucose of < 130 and HbA1c level of <6.5%

  up to 5 years

• Number of patients with improvement or worsening in exocrine function as measured by the estimation of fecal elastase >200 µg/g of stool or <200 µg/g of stool respectively at out patient clinic.

  up to 5 years

• Analgesics intake

  up to 5 years

• Weight gain in kg measured at out patient clinic

  up to 5 years

• Quality of life

  up to 5 years

Other Outcomes (3)

• Frequency of pain attacks

  Up to 5 years

• Time of disease related inability to work

  Up to 5 years

• Type of analgesic medication (morphine related analgesic potency)

  Up to 5 years

Study Arms (2)

GROUP 1

ACTIVE COMPARATOR

68 Patients undergo Frey's procedure with celiac plexus neurolysis using absolute alcohol

Procedure: celiac plexus neurolysis using absolute alcohol; Procedure: Frey's procedure

GROUP 2

PLACEBO COMPARATOR

68 Patients undergo Frey's procedure with Placebo celiac plexus injection using saline

Procedure: Placebo celiac plexus injection using saline; Procedure: Frey's procedure

Interventions

celiac plexus neurolysis using absolute alcohol PROCEDURE

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

Also known as: NCPB, Neurolytic celiac plexus block

GROUP 1

Placebo celiac plexus injection using saline PROCEDURE

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

Also known as: Placebo

GROUP 2

Frey's procedure 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.

Also known as: Duodenum preserving pancreatic head coring procedure

GROUP 1; GROUP 2

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive chronic calcific pancreatitis admitted in our institute since 2013 january with age group between 13 to 65 years with Visual analogue scale (VAS) pain score of more than 7 and those who have quit alcohol \& smoking for at least 6 months are included in our study.

You may not qualify if:

• Patients with mild to moderate pain score (VAS pain score 1-7), continuous substance abuse, severe comorbid illness are excluded from study.

Sponsors & Collaborators

• Madras Medical College: lead

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• KANNAN DEVYGOUNDER, MS,MCh,FRCS

  MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIA

  STUDY DIRECTOR

• BALAKUMARAN SATHYAMOORTHY

  MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 12, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2019
• Last Updated: April 12, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share