Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy

NCT ID: NCT05109143

Last Updated: 2022-07-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-17

Study Completion Date

2022-05-31

Brief Summary

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Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.

Detailed Description

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Conditions

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Pancreatoduodenectomy

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 B

Standard Medical Treatment

Group Type ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type OTHER

Standard Medical Treatment

Group A

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 Indomethacin Suppository administered at the time of Induction

Standard Medical Treatment

Intervention Type OTHER

Standard Medical Treatment

Interventions

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Indomethacin suppository

100mg Indomethacin Suppository administered at the time of Induction

Intervention Type DRUG

Standard Medical Treatment

Standard Medical Treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All consenting adults planned to undergo pancreatoduodenectomy,

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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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viniyendra Pamecha, FEBS

Role: STUDY_DIRECTOR

Institute of Liver & Biliary Sciences

Locations

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Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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IEC/2020/81/MA13

Identifier Type: -

Identifier Source: org_study_id

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