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
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 主要终点
- Pain relief measured by Visual Analogue Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with mild to moderate pain score (VAS pain score 1-7), continuous substance abuse, severe comorbid illness are excluded from study.
结局指标
主要结局
Pain relief measured by Visual Analogue Scale
时间窗: up to 5 years
Short term (2 years) and long term(5 years) score at follow up at out patient clinic or over phone.
次要结局
- 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)
- Number of patients with worsening in endocrine function as measured by abnormal laboratory values like Fasting glucose >130 and HbA1c >6.5(up to 5 years)
- 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)
研究者
Balakumaran Sathyamoorthy
Principal investigator
Madras Medical College