Condition: Post-ERCP Pancreatitis · Sponsor: Changhai Hospital
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks. This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation. Th…
This description comes directly from the study's public registry record.
Liang-Hao Hu · +8613817593520 · lianghao-hu@hotmail.com
Zhao-Shen Li · zhaoshen-li@hotmail.com
Always discuss trial participation with your own doctor first.
| Changhai Hospital | Shanghai, China | Not Yet Recruiting |
| Ruijin Hospital | Shanghai, China | Recruiting |
| Shanghai General Hospital | Shanghai, China | Not Yet Recruiting |
| Affiliated Hospital of Jiaxing University | Zhejiang, China | Not Yet Recruiting |
| Dongyang People's Hospital | Zhejiang, China | Not Yet Recruiting |
| First Affiliated Hospital of Ningbo University | Zhejiang, China | Not Yet Recruiting |
| Jinhua Central Hospital | Zhejiang, China | Not Yet Recruiting |
| People's Hospital of Quzhou | Zhejiang, China | Not Yet Recruiting |
| Shaoxing People's Hospital | Zhejiang, China | Not Yet Recruiting |
| Sir Run Run Shaw Hospital | Zhejiang, China | Recruiting |
| Taizhou Enze Medical Center Group | Zhejiang, China | Recruiting |
| Zhuji People's Hospital of Zhejiang Province | Zhejiang, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07088757