NCT06899269

SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: Hospital General Universitario de Alicante · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions. Methodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies. All adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.

Conditions

• Robotic Surgical Procedures
• Pancreatic Diseases

Interventions

Type	Name	Description
DEVICE	robotic resection with Da Vinci Xi	robotic resection with Da Vinci Xi

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-06-30
• Completion: 2029-06-30
• First posted: 2025-03-27
• Last updated: 2025-03-27

Regulatory

• FDA-regulated device study