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Comparing Robotic, Laparoscopic, and Open Surgery for Periampullary Tumors: Early Outcomes and Patient Experience - A clinical trial

Early post operative outcomes and PROM following Robotic-Assisted Pancreaticodiodenectomy RAW Laparoscopic-Assisted Pancreaticoduodenectomy LAW and Open Whipples Pancreaticoduodenectomy OWL a three arm RCT - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097887
Enrollment
75
Registered
2025-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: C250- Malignant neoplasm of head of pancreas

Interventions

Intervention1: Robotic Assisted Pancreaticoduodenectomy: Under General Anaesthesia, Parts will be painted and draped Robotic Ports will be placed as follows: R1 - 8MM - Fenestrated bipolar forceps R2

Sponsors

Dr Asuri Krishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (age 18 years or older). Surgical Obstructive Jaundice with diagnosed proven PeriAmpullary mass - requiring Pancreaticoduodenectomy Benign, premalignant/malignant Pancreatic diseases requiring Pancreaticoduodenectomy

Exclusion criteria

Exclusion criteria: metastatic disease Presence of unresectable tumor detected pre-operative or intra-operatively BMI more than 35 kg/m2 Patients with ongoing pancreatitis Patients with previous abdominal surgery Patients with absolute contraindications of laparoscopic surgeries Pregnancy

Design outcomes

Primary

MeasureTime frame
Morbidity as per Clavein-Dindo ClassificationTimepoint: At the time of discharge, 1 month and 3 months

Secondary

MeasureTime frame
MortalityTimepoint: At discharge, 1 month and 3 months;Wound infection rateTimepoint: At discharge, 1 month and 3 months;Operative timeTimepoint: Intraoperative;Duration of hospital stayTimepoint: At discharge;Rates of clinically relevant - postoperative pancreatic fistulaTimepoint: post operative day 3, day 5 and At discharge;Conversion rate from Robotic assisted Pancreatico-duodenectomy to Open Pancreatico-duodenectomyTimepoint: Intraoperative;Conversion rate from laparoscopic assisted Pancreatico-duodenectomy to open Pancreatico-duodenectomyTimepoint: Intraoperative

Countries

India

Contacts

Public ContactDr Vedant Kashikar

All india institute of medical sciences, New delhi

dr.asurikrishna@gmail.com9999405767

Outcome results

None listed

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