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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05109143

Enrollment

Registered

2021-11-05

Start date

2020-10-17

Completion date

2022-05-31

Last updated

2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatoduodenectomy

Brief 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.

Interventions

DRUGIndomethacin suppository

100mg Indomethacin Suppository administered at the time of Induction

OTHERStandard Medical Treatment

Standard Medical Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Post-operative Pancreatitis	first 30 days following pancreatoduodenectomy

Secondary

Measure	Time frame
delayed gastric emptying	First 30 days following pancreatoduodenectomy
intra-abdominal abscess	first 30 days following pancreatoduodenectomy
Post-operative Pancreatic Fistula	first 30 days following pancreatoduodenectomy
Length of hospital stay	First 30 days following pancretoduodenectomy
risk factors of post-operative pancreatitis	first 30 days following pancreatoduodenectomy
Length of ICU stay	First 30 days following pancreatoduodenectomy

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026