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Completed

NCT Number: NCT05109143

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion criteria

  • asthma
  • allergic reactions to NSAIDs
  • CKD
  • internal hemorrhoids
  • anti-platelet medications

Treatment and study plan

Indomethacin suppository

Drug

100mg Indomethacin Suppository administered at the time of Induction

Standard Medical Treatment

Other

Standard Medical Treatment

Primary outcomes

  1. Post-operative Pancreatitis

    Time frame: first 30 days following pancreatoduodenectomy

Secondary outcomes

  1. Post-operative Pancreatic Fistula

    Time frame: first 30 days following pancreatoduodenectomy

  2. delayed gastric emptying

    Time frame: First 30 days following pancreatoduodenectomy

  3. intra-abdominal abscess

    Time frame: first 30 days following pancreatoduodenectomy

  4. Length of ICU stay

    Time frame: First 30 days following pancreatoduodenectomy

  5. Length of hospital stay

    Time frame: First 30 days following pancretoduodenectomy

  6. risk factors of post-operative pancreatitis

    Time frame: first 30 days following pancreatoduodenectomy

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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