SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery) (SPAROBOPAN)

Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Diseases; Robotic Surgical Procedures
• Intervention / Treatment: Device: robotic resection with Da Vinci Xi

• Study Type: Observational
• Enrollment (Estimated): 225

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo robotic pancreatic resections

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Less than 18 years old.
• ASA IV

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Duoneopancreatectomy; Resection of the head of the pancreas	Device: robotic resection with Da Vinci Xi; robotic resection with Da Vinci Xi
Distal pancreatectomy; Resection of the body and the tail of the pancreas	Device: robotic resection with Da Vinci Xi; robotic resection with Da Vinci Xi
Total pancreatectomy; Total removal of the pancreas	Device: robotic resection with Da Vinci Xi; robotic resection with Da Vinci Xi
central pancreatectomy; body or neck of the pancreas resection	Device: robotic resection with Da Vinci Xi; robotic resection with Da Vinci Xi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Clavien-Dindo Classification	90 postoperative days
Postoperative complications	CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.	90 postoperative days
Number of robotic procedures	Number of robotic pancreatic procedures	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of each group in robotic pancreatic surgery	Questonnaire answering the number of robotic procedures in 2024.	1 year
Textbook outcome	Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay	1 year
Total survival	survival after surgery in months	3 years
Disease-free survival	Time from surgery to recurrence	3 years

Collaborators and Investigators

• Sponsor: Hospital General Universitario de Alicante

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 2024-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to local law with personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No