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

Phase 4

Recruiting

• Conditions: Organ Failure, Multiple; Acute Pancreatitis; Mortality Rate; Complication
• Interventions: Drug: Indomethacin SR; Drug: Placebos

• Registration Number: NCT03547232
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-06
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Primary Completion: 2028-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1428

Inclusion Criteria

• All patients ages 18-80 years admitted to Peking Union Medical College Hospital (PUMCH) with a diagnosis of AP based on at least 2 of the following criteria:
• Abdominal pain characteristic of AP
• Serum amylase and/or lipase ≥ 3 times the upper limit of normal
• Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

Exclusion Criteria

• Onset time >48 hours
• Presence of renal dysfunction (serum creatinine > 1.5 *normal upper limit)
• Active peptic ulcer disease or GI bleeding
• Pregnancy or breast-feeding
• Use of daily antiplatelet or anticoagulant drug(s) within 2 week of presentation
• Hypersensitivity to NSAIDs
• New-onset, exacerbation or uncontrolled hypertension
• Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke
• Mental disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indomethacin group	Indomethacin SR	Indomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.
Standard group	Placebos	Similar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible.

Primary Outcome Measures

Name	Time	Method
Occurence rate of organ dysfunction	1 week	Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems

Secondary Outcome Measures

Name	Time	Method
Occurence rate of pancreatic necrosis	1 month	Accumulation of the key local complication of acute pancreatitis
Incidence rate of ICU admission	1 month	Evaluation of critical severe acute pancreatitis
Mortality	1 month	The number of deaths during a particular period of time

Trial Locations

Locations (17)

Peking University Sixth Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, 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

Liangxiang Hospital; 🇨🇳 Beijing, Beijing, China