Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

NCT ID: NCT05722548

Last Updated: 2023-02-10

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-02-01

Brief Summary

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The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Detailed Description

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The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Conditions

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Pancreatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Group Type EXPERIMENTAL

Indomethacin suppository

Intervention Type DRUG

100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia

Standard Medical Treatment

Intervention Type OTHER

Standard Medical Treatment

Group B

Standard Medical Treatment

Group Type ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type OTHER

Standard Medical Treatment

Interventions

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Indomethacin suppository

100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia

Intervention Type DRUG

Standard Medical Treatment

Standard Medical Treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\*All patients planned to undergo pancreatectomy.

Exclusion Criteria

* asthma
* allergic reactions to NSAIDs
* CKD
* internal hemorrhoids
* anti-platelet medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yingbin Liu, MD, PhD, FACS

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yingbin Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

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Yingbin Liu, PHD

Role: CONTACT

+8613918803900

Other Identifiers

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LYBWWG2023

Identifier Type: -

Identifier Source: org_study_id

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