Health Condition 1: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C170- Malignant neoplasm of duodenum Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: C250- Malignant neoplasm of head of pancreas Health Condition 5: K838- Other specified diseases of biliary tract Health Condition 6: K868- Other specified diseases of pancreas Health Condition 7: null- Patients undergoing Whipples Pancreaticoduodenectomy for relevant indications
Conditions
Interventions
Intervention1: Intravenous hydrocortisone 100mg: Total 8 doses. First dose at induction of anaesthesia. Remaining doses at thrice a day frequency for total 3 days.
Intervention2: rectal indomethacin s
Sponsors
ASIAN INSTITUTE OF GASTROENTEROLOGY
Eligibility
Inclusion criteria
Inclusion criteria: • 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).
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Major overall complication rate (Clavienâ??Dindo class II, III , IV & V)Timepoint: Upto 30 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Post operative pancreatic fistula rate â?¢ Post pancreatectomy haemorrhage rate â?¢ Delayed gastric emptying rate â?¢ Surgical site infection rate â?¢ Post operative drain fluid amylase on post operative day 3,5 and 7 (required to establish the diagnosis of pancreatic fistula) â?¢ Days of drain removal (operatively placed drains are retained in the patients having pancreatic fistula) â?¢ Number of days of ICU stay â?¢ Overall days of hospitalization â?¢ Re-admission rateTimepoint: Upto 30 days after surgery | — |
Countries
India
Contacts
Public ContactKislay Kant
ASIAN INSTITUTE OF GASTROENTEROLOGY, HYDERABAD
Outcome results
None listed