Role of indomethacin suppository as a possible means to reduce complications related to Pancreatoduodenectomy.

Phase 2/3

Recruiting

• Conditions: Malignant neoplasm of head of pancreas, (2) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (3) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (4) ICD-10 Condition: K838||Other specified diseases of biliary tract, (5) ICD-10 Condition: K862||Cyst of pancreas, (6) ICD-10 Condition: K860||Alcohol-induced chronic pancreatitis, (7) ICD-10 Condition: K861||Other chronic pancreatitis, (8) ICD-10 Condition: K831||Obstruction of bile duct,

• Registration Number: CTRI/2020/09/028027
• Lead Sponsor: Institute of Liver and Biliary Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-30
• Last Update Posted: 2020-12-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

All consenting adults planned to undergo pancreatoduodenectomy.

Exclusion Criteria

• Patients refusing to consent 2.
• History of asthma 3.
• History of allergic reactions to NSAIDs 4.
• History of renal dysfunction or CKD 5.
• E/o Internal hemorrhoids on examination 6.
• Patients on Anti-platelet drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Post-operative Pancreatitis	Within 30 days of surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative pancreatic fistula rate	within 30 days of surgery
Post-pancreaticoduodenectomy hemorrhage rate	within 30 days of surgery
Delayed Gastric emptying rate	within 30 days of surgery
Intra-abdominal collections/abscess rates	within 30 days of surgery
Duration of ICU stay	within 30 days of surgery
Length of Hospital Stay	within 30 days of surgery
Risk factors for post-operative pancreatitis	within 30 days of surgery

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 West, DELHI, India

Institute of Liver and Biliary Sciences

🇮🇳West, DELHI, India

Anubhav

Principal investigator

8860188337

anubhav.pawar@gmail.com