Role of hydrocortisone and indomethacin in reducing major complications after Whipples pancreaticoduodenectomy
- Conditions
- Health Condition 1: C241- Malignant neoplasm of ampulla of VaterHealth Condition 2: C170- Malignant neoplasm of duodenumHealth Condition 3: C240- Malignant neoplasm of extrahepaticbile ductHealth Condition 4: C250- Malignant neoplasm of head of pancreasHealth Condition 5: K838- Other specified diseases of biliary tractHealth Condition 6: K868- Other specified diseases of pancreasHealth Condition 7: null- Patients undergoing Whipples Pancreaticoduodenectomy for relevant indications
- Registration Number
- CTRI/2018/06/014541
- Lead Sponsor
- ASIAN INSTITUTE OF GASTROENTEROLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
•All patients undergoing Whippleâ??s PD in Asian Institute of Gastroenterology, Hyderabad
•Patients having >40% acini at cut surface of pancreas ( previous studies have shown that those patients in whom pancreas contain more number of acini are tend to have softer pancreas, more local inflammatory response and hence more chances of Anastomotic leak. Only those patients who are at high risk for leak i.e. more than 40% acini in cut surface of pancreas will be included in the study and recieve the remaining doses of drugs and followed up).
•On table - inoperable patients
•Patients already on steroid treatment
•Patients already on long term NSAIDs treatment
•Patients with Chronic pancreatitis (these patients are at low risk of leak due to hard texture of pancreas, hence will be excluded from the study)
•Patients of Chronic kidney disease
•Patients who suffered stroke or acute coronary syndrome in past
•Known case of peptic ulcer disease
•Patients having thrombocytopenia
•Patients not giving consent for participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Major overall complication rate (Clavienâ??Dindo class II, III , IV & V)Timepoint: Upto 30 days after surgery
- Secondary Outcome Measures
Name Time Method â?¢Post operative pancreatic fistula rate <br/ ><br>â?¢Post pancreatectomy haemorrhage rate <br/ ><br>â?¢Delayed gastric emptying rate <br/ ><br>â?¢Surgical site infection rate <br/ ><br>â?¢Post operative drain fluid amylase on post operative day 3,5 and 7 (required to establish the diagnosis of pancreatic fistula) <br/ ><br>â?¢Days of drain removal (operatively placed drains are retained in the patients having pancreatic fistula) <br/ ><br>â?¢Number of days of ICU stay <br/ ><br>â?¢Overall days of hospitalization <br/ ><br>â?¢Re-admission rateTimepoint: Upto 30 days after surgery