Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

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.

Conditions

• Acute Pancreatitis
• Complication
• Mortality Rate
• Organ Failure, Multiple

Interventions

DRUG

Indomethacin SR

Indomethacin SR 50mg given q12h from admission day 1 to day 7

DRUG

Placebos

Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Dong Wu, M.D. · Peking Union Medical College Hospital

• Zhitao Lu, M.D. · Baoding Seventh Hospital

• Yanfeng Wang, M.D. · Liangxiang Hospital

• Shanshan Yu, M.D. · Guiyang Second People's Hospital

• Na Wu, M.D. · Dengzhou People's Hospital

• Mei Liu, M.D. · Affiliated Hospital of Qinghai University

• Xiao Fan, M.D. · Second People Hospital of Nanyang

• Zuoyan Wu, MD · Peking University Sixth Hospital

• Ruifeng Wang, MD · Harbin Medical University

• Baofeng Zhu, MD · Nantong First People's Hospital

• Yan Shi, MD · The Second People's Hospital of Huai'an

• Ming Sun, MD · Suqian People's Hospital

• Wei Huang, MD · Wuxi Third People's Hospital

• Shicheng Zheng, MD · West China Longquan Hospital Sichuan University

• Jianzhong Yang, MD · First Affiliated Hospital of Xinjiang Medical University

• Daoyuan Jing, MD · Jinhua Municipal Central Hospital

• Hong Liu, MD · Lishui Municipal Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2028-06-01

Completion

2028-12-01

Countries

• China

Study Locations