Dose-escalation of Rectal Indomethacin for Preventing PEP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard-dose group VS high-dose group.
- Who it may be relevant to
- Registry conditions: Post-ERCP Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dose-escalation of Rectal Indomethacin for Post-ERCP Pancreatitis Prevention in High-risk Patients: Protocol of a Multicentre Randomised Clinical Trial
Overview
Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).
Detailed description
Evidence suggests that escalating the rectal indometacin dose to 200 mg offers no clear advantage over the standard 100 mg regimen in high-risk patients. However, the majority of participants (76%) had received pancreatic stent placement, raising the possibility that the benefit of the supplementary strategy may have been obscured by the considerable efficacy of pancreatic stenting. Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting.
Interventions
- Drug standard-dose group VS high-dose group
A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group)
Primary outcome measures
- the incidence and severity of PEP [Time frame: up to 1 months]
Eligibility criteria
Inclusion Criteria:Participants will be eligible for enrollment if they meet all of the following criteria: 1. age over 18 years; 2. classified as high risk for post-ERCP pancreatitis; 3. provision of signed, written informed consent.
Exclusion Criteria:Participants will be excluded if they meet any of the following conditions: 1. inaccessible major papilla; 2. surgically altered gastrointestinal anatomy; 3. current diagnosis of acute pancreatitis; 4. placement of a pancreatic stent; 5. contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including known allergy, renal insufficiency, or active peptic ulcer disease; 6. anticipated low risk of post-ERCP pancreatitis (e.g., patients with chronic calcific pancreatitis, pancreatic head mass, or those undergoing biliary interventions through a pre-existing sphincterotomy); 7.severe active cardiopulmonary disease; 8. pregnancy or breastfeeding; 9. presence of an ampullary tumor.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University — Hefei
Identifiers
NCT: NCT07247682 · FirstHAnhuiMU1