CTRI/2021/03/032127招募中不适用
Randomized comparative study to assess the efficacy of Oral Melatonin plus Rectal Indomethacin versus Rectal Indomethacin for the Prophylaxis of Post-Ercp Pancreatitis
BSBY Scheme Govt of Rajasthan1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- This classification defines three degrees of severity based on the presence or absence of organ failure ( plus its duration ) and of local or systemic complications.
研究概览
简要总结
It will be a prospective, Randomized Controlled comparative study to assess the efficacy of Oral Melatonin plus Rectal Indomethacin versus Rectal Indomethacin for the prevention of Post Ercp Pancreatitis.
All the patients fulfilling the inclusion criteria will be randomized into two groups . Primary and secondary end points will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •ALL PATIENTS UNDERGOING ERCP IN THE DEPARTMENT OF GASTROENTEROLOGY, SMS HOSPITAL OVER A PERIOD OF 6 MONTHS.
排除标准
- •History of hypersensitivity to Indomethacin 2) History of hypersensitivity to Melatonin 3) Recent Peptic ulcer disease or active/ recent gastrointestinal bleeding within 4 weeks.
- •Renal dysfunction (creatinine > 1.5 mg/dl) 5) NSAID use during preceding week (acetylsalicylic acid 325 mg daily or less was acceptable) 6) Acute pancreatitis during the 2 weeks before ERCP 7) History of chronic pancreatitis 8) Previous sphincterotomy 9) Refusal to participate in the study.
- •Pregnancy or lactation 11) Patients undergoing ERCP on an outpatient basis.
结局指标
主要结局
This classification defines three degrees of severity based on the presence or absence of organ failure ( plus its duration ) and of local or systemic complications.
时间窗: within 24 hours Post ERCP
1) Frequency of Post-ERCP Pancreatitis, defined according to the revised Atlanta classification.
时间窗: within 24 hours Post ERCP
次要结局
- 1) Incidence of Delayed Post - ERCP pancreatitis ( 24 hours after ERCP )(2) Severity of PEP)
研究者
研究点 (1)
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