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CompletedNCT05109143Updated Jul 6, 2022

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

An interventional study of Indomethacin suppository and Standard Medical Treatment in Pancreatoduodenectomy, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2020, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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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Conditions studied

  • Pancreatoduodenectomy

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03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

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Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Group B

    Standard Medical Treatment

    Other: Standard Medical Treatment

  • Experimental
    Group A

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

    Drug: Indomethacin suppository · Other: Standard Medical Treatment

Interventions

  • DrugIndomethacin suppository

    100mg Indomethacin Suppository administered at the time of Induction

  • OtherStandard Medical Treatment

    Standard Medical Treatment

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What researchers measure

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

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Study locations

1 site
  • Institute of Liver & Biliary Sciences
    New Delhi, Delhi 110070, India
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05109143
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Oct 17, 2020
Primary completion
Apr 30, 2022
Completion
May 31, 2022
Last update
Jul 6, 2022

Study contacts

Viniyendra Pamecha, FEBS
study director · Institute of Liver & Biliary Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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