study to assess the efficacy of oral melatonin plus rectal indomethacin versus rectal indomethacin for the prevention of post-ercp pancreatitis

Recruiting

• Conditions: Cholangitis, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: K831||Obstruction of bile duct,

• Registration Number: CTRI/2021/03/032127
• Lead Sponsor: BSBY Scheme Govt of Rajasthan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

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
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.	within 24 hours Post ERCP
1) Frequency of Post-ERCP Pancreatitis, defined according to the revised Atlanta classification.	within 24 hours Post ERCP

Secondary Outcome Measures

Name	Time	Method
1) Incidence of Delayed Post - ERCP pancreatitis ( 24 hours after ERCP )	2) Severity of PEP

Trial Locations

Locations (1)

SMS Medical college, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

SMS Medical college, Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Rishabh gupta

Principal investigator

9588248715

rishabh1313@gmail.com