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

Randomized comparative study to assess the efficacy of Oral Melatonin plus Rectal Indomethacin versus Rectal Indomethacin for the Prophylaxis of Post-Ercp Pancreatitis - PEP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032127
Enrollment
300
Registered
2021-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K830- Cholangitis Health Condition 2: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 3: K831- Obstruction of bile duct

Interventions

Intervention1: Oral Melatonin plus Rectal Indomethacin: 3 mg oral melatonin with 100 mg rectal indomethacin ( two 50 mg suppositories ) will be given 1 hour before the ERCP procedure Control Intervent

Sponsors

BSBY Scheme Govt of Rajasthan
Lead Sponsor
Rajasthan medicare relief society
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ALL PATIENTS UNDERGOING ERCP IN THE DEPARTMENT OF GASTROENTEROLOGY, SMS HOSPITAL OVER A PERIOD OF 6 MONTHS

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1) Frequency of Post-ERCP Pancreatitis, defined according to the revised Atlanta classification. 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

MeasureTime frame
1) Incidence of Delayed Post - ERCP pancreatitis ( 24 hours after ERCP ) 2) Severity of PEP 3) ERCP-related complications namely bleeding, perforation, and infection 4)Hydration-related complications, such as pulmonary edema and congestive heart failureTimepoint: after 24 hours post ercp , upto 30 days—

Countries

India

Contacts

Public ContactDr Rishabh gupta

sawai man singh medical college, jaipur

rishabh1313@gmail.com9588248715

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026