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

Chronic Calcific Pancreatitis Clinical Trial

— INFARCT  

Official title:

Intra Operative Coeliac Plexus Neurolysis Combined With Frey's Procedure for Effective Pain Relief in Patients With Chronic Calcific Pancreatitis- A Prospective Randomized Double-blind Placebo Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02735330
• Other study ID #: ID-NO 23052015
• Secondary ID: CTRI/2016/02/006
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2016
• Last updated: April 11, 2016
• Start date: January 2013
• Est. completion date: September 2019

Study information

• Verified date: April 2016
• Source: Madras Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: September 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Calcific Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Madras Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of pain attacks	whether pain attacks are occurring in a daily/several times in a week/month/Year is noted.	Up to 5 years	No
Other	Time of disease related inability to work	Whether the restriction of work activities last permanently/ Up to 1 year/month/week or no restriction is noted	Up to 5 years	No
Other	Type of analgesic medication (morphine related analgesic potency)	What analgesic medication is taken by the patient like morphine,pethidine,buprenorphine, tramadol,aspirin, paracetamol are noted.	Up to 5 years	No
Primary	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	No
Secondary	Number of patients with improvement in endocrine function as measured by Fasting glucose of < 130 and HbA1c level of <6.5%	and reduction in dosage of insulin (iu) & oral hypoglycemic agents (milli gm) when compared to preoperative levels- at out patient clinic	up to 5 years	No
Secondary	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	No
Secondary	Analgesics intake	Dosage and frequency of intake of both NSAIDs and opioid analgesics intake are noted at out patient clinic or over phone.	up to 5 years	No
Secondary	Weight gain in kg measured at out patient clinic		up to 5 years	No
Secondary	Quality of life	Using SF 12 V2 (Tamil and english version-Optuminsight Life Sciences) in a face to face (written form) interview at out patient clinic	up to 5 years	No
Secondary	Number of patients with worsening in endocrine function as measured by abnormal laboratory values like Fasting glucose >130 and HbA1c >6.5	and increased dosage of insulin (IU)& oral hypoglycemic agents(milli gms) requirement when compared to preoperative levels at out patient clinic	up to 5 years	No
Secondary	Number of patients with abnormal lab values like Fasting glucose of >126 mg/dl or blood glucose level of >200 after a standard glucose tolerance test (GTT) in equivocal cases.		up to 5 years	No