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