To study the impact of intra operative hydrocortisone on postoperative pancreatic fistula in patient undergoing pancreaticoduodenectomy

Effect of perioperative intravenous hydrocortisone on clinically relevant postoperative pancreatic fistula in patients undergoing classical Whipple pancreaticoduodenectomy: a prospective randomized controlled pilot study - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099871

Enrollment

Registered

2025-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C170- Malignant neoplasm of duodenum Health Condition 3: C250- Malignant neoplasm of head of pancreas Health Condition 4: C248- Malignant neoplasm of overlappingsites of biliary tract

Interventions

Intervention1: Peri operative hydrocortisone administration: After the induction of anaesthesia and endotracheal intubation, each patient will be assigned to one of two groups through the use of a set

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to give consent for being a participant in the study. 2. Either gender. 3. Age group of 18-80 years. 4. Patients undergoing elective Classical Whipple pancreaticoduodenectomy for benign and malignant aetiology.

Exclusion criteria

Exclusion criteria: .Patients not giving informed consent. 2. Patients undergoing total pancreatectomy, distal pancreatectomy, pylorus preserving PD, enucleation. 3. Chronic use of corticosteroids or immunosuppressive drugs. 4. Known allergy or contraindications to corticosteroids.

Design outcomes

Primary

Measure	Time frame
To study the impact of intraoperative hydrocortisone on postoperative pancreatic fistula in patient undergoing pancreaticoduodenectomy.Timepoint: 4 weeks	—

Secondary

Measure	Time frame
To evaluate the severity of POPF.Timepoint: 4 weeks;To analyse secondary outcomes, including length of hospital stay, postoperative complications (POPF, DGE, hemorrhage, intra-abdominal collection, biliary fistula, respiratory tract infection, urinary tract infection) and mortality.Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactShivansh Saraswat

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

kamanlil@yahoo.com9878254574

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026