SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

NCT06899269 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2025-03-27

No results posted yet for this study

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

Interventions

DEVICE

robotic resection with Da Vinci Xi

robotic resection with Da Vinci Xi

Sponsors & Collaborators

  • Hospital General Universitario de Alicante

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-06-30
Completion
2029-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899269 on ClinicalTrials.gov