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

Pancreatoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109143
• Other study ID #: IEC/2020/81/MA13
• Status: Completed
• Phase: N/A
• Start date: October 17, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All consenting adults planned to undergo pancreatoduodenectomy,

Exclusion Criteria:

• asthma

• allergic reactions to NSAIDs

• CKD

• internal hemorrhoids

• anti-platelet medications

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatoduodenectomy

Intervention

Drug:
• Indomethacin suppository
100mg Indomethacin Suppository administered at the time of Induction

Other:
• Standard Medical Treatment
Standard Medical Treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

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