Dose-escalation of Rectal Indomethacin for Preventing PEP

The First Affiliated Hospital of Anhui Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Post-ERCP Pancreatitis

Treatments: Drug: standard-dose group VS high-dose group

Study type: Interventional

Funder types: Other

Identifiers

NCT07247682

FirstHAnhuiMU1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,036 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,036 participants in 2 patient groups

standard-dose group

Active Comparator group

Description:

administration of 100 mg rectal indometacin immediately after ERCP

Treatment:

Drug: standard-dose group VS high-dose group

high-dose group

Experimental group

Description:

administration of 200 mg rectal indometacin immediately after ERCP

Treatment:

Drug: standard-dose group VS high-dose group