SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

Hospital General Universitario de Alicante

Status: Not yet enrolling

Conditions: Pancreatic Diseases; Robotic Surgical Procedures

Treatments: Device: robotic resection with Da Vinci Xi

Study type: Observational

Funder types: Other

Identifiers

NCT06899269

2024-089

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Less than 18 years old.
• ASA IV

Trial design

225 participants in 4 patient groups

Duoneopancreatectomy

Description:

Resection of the head of the pancreas

Treatment:

Device: robotic resection with Da Vinci Xi

Distal pancreatectomy

Description:

Resection of the body and the tail of the pancreas

Treatment:

Device: robotic resection with Da Vinci Xi

Total pancreatectomy

Description:

Total removal of the pancreas

Treatment:

Device: robotic resection with Da Vinci Xi

central pancreatectomy

Description:

body or neck of the pancreas resection

Treatment:

Device: robotic resection with Da Vinci Xi