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SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06899269
Acronym
SPAROBOPAN
Enrollment
225
Registered
2025-03-27
Start date
2025-04-01
Completion date
2029-06-30
Last updated
2025-03-27

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

Conditions

Pancreatic Diseases, Robotic Surgical Procedures

Brief 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.

Interventions

DEVICErobotic resection with Da Vinci Xi

robotic resection with Da Vinci Xi

Sponsors

Hospital General Universitario de Alicante
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* robotic pancreatic resections * Asa I-III * Signed informed consent

Exclusion criteria

* Less than 18 years old. * ASA IV

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications90 postoperative daysClavien-Dindo Classification
Number of robotic procedures1 yearNumber of robotic pancreatic procedures

Secondary

MeasureTime frameDescription
Experience of each group in robotic pancreatic surgery1 yearQuestonnaire answering the number of robotic procedures in 2024.
Textbook outcome1 yearComposite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay
Total survival3 yearssurvival after surgery in months
Disease-free survival3 yearsTime from surgery to recurrence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026