study to assess the efficacy of oral melatonin plus rectal indomethacin versus rectal indomethacin for the prevention of post-ercp pancreatitis
Not Applicable
- Conditions
- Health Condition 1: K830- CholangitisHealth Condition 2: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhereHealth Condition 3: K831- Obstruction of bile duct
- Registration Number
- CTRI/2021/03/032127
- Lead Sponsor
- BSBY Scheme Govt of Rajasthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ALL PATIENTS UNDERGOING ERCP IN THE DEPARTMENT OF GASTROENTEROLOGY, SMS HOSPITAL OVER A PERIOD OF 6 MONTHS
Exclusion Criteria
1) History of hypersensitivity to Indomethacin
2) History of hypersensitivity to Melatonin
3) Recent Peptic ulcer disease or active/ recent
gastrointestinal bleeding within 4 weeks.
4) 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.
10) Pregnancy or lactation
11) Patients undergoing ERCP on an outpatient basis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Frequency of Post-ERCP Pancreatitis, defined according to the revised Atlanta classification. <br/ ><br>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.Timepoint: within 24 hours Post ERCP
- Secondary Outcome Measures
Name Time Method 1) Incidence of Delayed Post - ERCP pancreatitis ( 24 hours after ERCP ) <br/ ><br>2) Severity of PEP <br/ ><br>3) ERCP-related complications namely bleeding, perforation, and infection <br/ ><br>4)Hydration-related complications, such as pulmonary edema and congestive heart failureTimepoint: after 24 hours post ercp , upto 30 days