Clinical trial NCT02735330: Intraoperative Coeliac Plexus Alcohol Neurolysis Along With Frey's Procedure for a Better Pain Relief
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Calcific Pancreatitis
Keywords: CCP
Lead sponsor: Madras Medical College
Sponsor class: OTHER_GOV
First posted: 2016-04-12
Enrollment: 136
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain relief measured by Visual Analogue Scale
timeFrame: up to 5 years
Secondary outcomes:
measure: Number of patients with improvement in endocrine function as measured by Fasting glucose of < 130 and HbA1c level of <6.5%
timeFrame: up to 5 years
measure: 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.
timeFrame: up to 5 years
measure: Analgesics intake
timeFrame: up to 5 years
measure: Weight gain in kg measured at out patient clinic
timeFrame: up to 5 years
measure: Quality of life
timeFrame: up to 5 years
measure: Number of patients with worsening in endocrine function as measured by abnormal laboratory values like Fasting glucose >130 and HbA1c >6.5
timeFrame: up to 5 years
measure: 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.
timeFrame: up to 5 years
Other outcomes:
measure: Frequency of pain attacks
timeFrame: Up to 5 years
measure: Time of disease related inability to work
timeFrame: Up to 5 years
measure: Type of analgesic medication (morphine related analgesic potency)
timeFrame: Up to 5 years
Locations:
Study officials:
affiliation: MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIA
name: KANNAN DEVYGOUNDER, MS,MCh,FRCS
role: STUDY_DIRECTOR
affiliation: MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA
name: BALAKUMARAN SATHYAMOORTHY
role: PRINCIPAL_INVESTIGATOR
References: