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Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)
Sponsor: Peking Union Medical College Hospital
Summary
Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.
Official title: Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1504
Start Date
2024-12-01
Completion Date
2028-12-01
Last Updated
2025-06-15
Healthy Volunteers
No
Interventions
Indomethacin SR
Indomethacin SR 50mg given q12h from admission day 1 to day 7
Placebos
Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
Locations (17)
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Liangxiang Hospital
Beijing, Beijing Municipality, China
Guiyang Second People's Hospital
Guiyang, Guizhou, China
Baoding Seventh Hospital
Baoding, Hebei, China
Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Dengzhou People's Hospital
Dengzhou, Henan, China
Second People Hospital of Nanyang
Nanyang, Henan, China
The Second People's Hospital of Huai'an
Huaian, Jiangsu, China
Nantong First People's Hospital
Nantong, Jiangsu, China
Suqian People's Hospital
Suqian, Jiangsu, China
Wuxi Third People's Hospital
Wuxi, Jiangsu, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
West China Longquan Hospital Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, China