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A randomized trial to compare the complications and oncological outcomes between two techniques of robotic and laparoscopic pancreatoduodenectomy done for periampullary cancer

Peri-operative and Oncological Outcomes of Robotic Vs Laparoscopic Pancreatoduodenectomy: A Randomised Controlled Trial - ROBOLA Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098288
Enrollment
84
Registered
2025-12-02
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: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 3: C250- Malignant neoplasm of head of pancreas

Interventions

Intervention1: Robotic Pancreatoduodenectomy: Analysis of perioperative and oncological outcomes of Robotic Pancreatoduodenectomy and comparing it with Laparoscopic Pancreatoduodenectomy. Total Dura

Sponsors

Vaibhav Kumar Varshney
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Age above 18 years b) Patients undergoing minimally invasive PD for clinically indicated malignant or premalignant lesions in the pancreatic and periampullary region c) Resectable lesion less than 4 cm in size without vascular invasion d) ECOG performance status 0 or 1 e) Absence of prohibitive cardiopulmonary comorbidities that preclude prolonged pneumoperitoneum f) Absence of uncorrected coagulopathy, chronic liver disease, or chronic renal disease

Exclusion criteria

Exclusion criteria: a) Pregnancy b) Previous history of major upper abdominal surgery c) Open or Hybrid Pancreatoduodenectomy d) Emergency Pancreatoduodenectomy e) Requirement for multi-visceral resection f) Borderline or locally advanced Pancreatic cancer

Design outcomes

Primary

MeasureTime frame
Major Surgical Complications at 30 days (Clavien Dindo Grade more than or equal to IIIa)Timepoint: Outcome will be assessed at the time of discharge after Pancreatoduodenectomy and at 90-day follow-up. Additionally, if there are any readmissions within the first 90 days after surgical intervention.—

Secondary

MeasureTime frame
a. Intraoperative: Operative duration, intraoperative blood loss, need for transfusion, conversion rate to open b. Postoperative: Delayed gastric emptying (DGE), postoperative pancreatic fistula (POPF), post pancreatectomy hemorrhage (PPH) as per ISGPS criteria (references), bile leak, surgical site infection, length of postoperative hospital stay, 30-day mortality, readmission, & resurgery rates c. Histopathological: Number of lymph nodes harvested, R0 resection rate Timepoint: Outcome will be assessed at the time of discharge after Pancreatoduodenectomy & at 90-day follow-up. Additionally, if there are any readmissions within the first 90 days after surgical intervention.—

Countries

India

Contacts

Public ContactVaibhav Kumar Varshney

All India Institute of Medical Sciences, Jodhpur

drvarshney09@gmail.com9968223072

Outcome results

None listed

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