SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital General Universitario de Alicante

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

robotic pancreatic resections

Asa I-III

Signed informed consent

Disqualifiers

Less than 18 years old.

ASA IV

Trial population

Patient who will undergo robotic pancreatic resections

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • robotic resection with Da Vinci Xi

    Device

    robotic resection with Da Vinci Xi

Treatment groups

225 Participants
are divided into 4 treatment groups
Group A: Duoneopancreatectomy1 intervention
Group B: Distal pancreatectomy1 intervention
Group C: Total pancreatectomy1 intervention
Group D: central pancreatectomy1 intervention

Trial outcomes

Primary outcomes

1

Postoperative complications

Clavien-Dindo Classification

Time frame
90 postoperative days
2

Postoperative complications

CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.

Time frame
90 postoperative days
3

Number of robotic procedures

Number of robotic pancreatic procedures

Time frame
1 year

Secondary outcomes

1

Experience of each group in robotic pancreatic surgery

Questonnaire answering the number of robotic procedures in 2024.

Time frame
1 year
2

Textbook outcome

Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay

Time frame
1 year
3

Total survival

survival after surgery in months

Time frame
3 years
4

Disease-free survival

Time from surgery to recurrence

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: