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Early Indomethacin for Preventing Organ Failure in Acute Pancreatitis: A Target Trial Emulation

Early Indomethacin for Preventing Organ Failure in Acute Pancreatitis: A Target Trial Emulation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109893
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Acute pancreatitis

Interventions

Indomethacin suppository treatment group:NA
Non-indomethacin suppository treatment group:NA

Sponsors

Department of Gastroenterology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years, inclusive. 2. Diagnosis of acute pancreatitis (AP) established by meeting at least two of the following three criteria: (1) Typical upper abdominal pain; (2) Serum lipase or amylase level at least three times the upper limit of normal (ULN); (3) Characteristic findings of AP on abdominal imaging. 3. Onset of abdominal pain symptoms <48 hours prior to inclusion.

Exclusion criteria

Exclusion criteria: 1. Use of any non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to enrollment. 2. History of active peptic ulcer or gastrointestinal bleeding within 30 days prior to enrollment. 3. Pregnancy or lactation. 4. Severe renal dysfunction, defined as a baseline serum creatinine level >1.5 times the upper limit of normal (ULN). 5. Severe hepatic dysfunction, evidenced by clinically significant liver disease at baseline, such as cirrhosis or acute liver failure. 6. Known history of hypersensitivity to NSAIDs. 7. New-onset, exacerbation, or uncontrolled hypertension within 30 days prior to enrollment. 8. History of a major adverse cardiovascular or cerebrovascular event (e.g., severe heart failure, myocardial infarction, or stroke) within 180 days prior to enrollment. 9. Pancreatitis caused by malignancy or post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis.

Design outcomes

Primary

MeasureTime frame
The occurrence of organ failure within 7 days;

Secondary

MeasureTime frame
All-cause mortality within 30 days;Length of hospital stay;Intensive care unit (ICU) admission;Length of stay in the ICU;Total hospitalization costs;Late local complications: development of pancreatic pseudocyst or walled-off necrosis diagnosed between 30 and 60 days after time zero;Peak serum C-reactive protein (CRP) level within the first 7 days;

Countries

China

Contacts

Public ContactDong Wu

Peking Union Medical College Hospital

wudong@pumch.cn+86 186 1267 1010

Outcome results

None listed

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