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โ† Trials
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Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis

RecruitingPhase 4Ages 18 Years - anyAllChanghai Hospital
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In plain words

What the trial is, and whether it could suit you

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 dete

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older. * Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography Exclusion Criteria: * Standard contraindications to ERCP * Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) * Use of NSAIDs within 7 days prior to ERCP * Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure) * Acute pancreatitis within 3 days before ERCP * Hemodynamic instability * Pregnancy or lactation * Patients who are unwilling or unable to provide informed consent
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What it tests

  • standard dose indomethacin
  • low dose indomethacin
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Where

12 sites
Changhai Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
Affiliated Hospital of Jiaxing University
Zhejiang, China
Dongyang People's Hospital
Zhejiang, China
First Affiliated Hospital of Ningbo University
Zhejiang, China
Jinhua Central Hospital
Zhejiang, China
People's Hospital of Quzhou
Zhejiang, China

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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