Dose-escalation of Rectal Indomethacin for Preventing PEP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1036 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-12-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Post-ERCP Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

For enhanced objectivity in data analysis, the project statisticians will be blinded to the arm allocation.

Study Groups

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standard-dose group

administration of 100 mg rectal indometacin immediately after ERCP

Group Type ACTIVE_COMPARATOR

standard-dose group VS high-dose group

Intervention Type DRUG

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)

high-dose group

administration of 200 mg rectal indometacin immediately after ERCP

Group Type EXPERIMENTAL

standard-dose group VS high-dose group

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG