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

NCT ID: NCT02735330

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-09-30

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.

Detailed Description

165 consecutive CCP patients admitted in our surgical gastro enterology department since January 2013 were screened for eligibility. 29 patients were excluded (28 were not meeting the inclusion criteria and 1 patient intra operatively found to have disseminated malignancy). After exclusion 136 patients were included in our study. They were randomized in to 2 groups, one group was treated by Frey's procedure with NCPB (Group-I) and the other by Frey's procedure with saline as placebo (Group-II). Method of Study is a randomized, double- blind, placebo- controlled, parallel arm, superiority trial.

Randomization was done at the time of surgery using random number table created with computerized software by a statistician not involved in this study.

Blinding and masking was done by using pre numbered containers having filled with either absolute alcohol or saline according to the randomization chart which was then kept sealed by an office staff until the end of the study. Both subjects and response assessor were blinded.

Data collection:

The preoperative baseline details such as etiology, morphology, associated complications and VAS pain score, Izbicki pain score, weight loss, insulin requirement, LFT (liver function tests), serum amylase & lipase, fasting sugar& fecal elastase were collected on admission.

Additional procedures, presence of peripancreatic inflammatory changes (fibrosis) as evidenced by difficult Kocherisation and plasted capsule and intra-operative complications were noted during surgery.

Short term follow up details including pain relief measured by VAS score &Izbicki pain score, analgesic consumption, weight gain, improvement in steatorrhoea (Fecal elastase>200 µg/g of stool & subjective reduction in foul smelling oily diarrhea), diabetic status (fasting glucose, GTT, HgbA1c, insulin& oral hypoglycemic agents requirement), mortality and morbidity were noted.

Follow up details were collected every 3 months as outpatient basis. Standard questionnaire format of SF 12 Version-2 was used for QOL assessment every 6 months in a face to face interview.

Statistical analysis was performed in SPSS version 20. Continuous variables were presented as mean, standard deviation and 95% confidence interval; categorical variables were presented as frequencies. The chi-square test and the Fisher exact test were used to analyze categorical variables. The unpaired Student t test was used to analyze continuous variables. P value <0.05 was considered statistically significant. Factors found significant on univariate logistic regression analysis were incorporated in to the multivariate logistic regression analysis for odds ratio with 95% confidence intervals to analyze the significant factors affecting the outcome of surgery.

Conditions

Chronic Calcific Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GROUP 1

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

Group Type: ACTIVE_COMPARATOR

celiac plexus neurolysis using absolute alcohol

Intervention Type: 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

Frey's procedure

Intervention Type: 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.

GROUP 2

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

Group Type: PLACEBO_COMPARATOR

Placebo celiac plexus injection using saline

Intervention Type: 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

Frey's procedure

Intervention Type: 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.

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

NCPB, Neurolytic celiac plexus block; Placebo; Duodenum preserving pancreatic head coring procedure

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Madras Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Balakumaran Sathyamoorthy

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KANNAN DEVYGOUNDER, MS,MCh,FRCS

Role: STUDY_DIRECTOR

MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIA

BALAKUMARAN SATHYAMOORTHY

Role: PRINCIPAL_INVESTIGATOR

MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA

Other Identifiers

CTRI/2016/02/006593

Identifier Type: REGISTRY

Identifier Source: secondary_id

ID-NO 23052015

Identifier Type: -

Identifier Source: org_study_id