SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

NCT06899269 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-089
• Study Type: observational
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Robotic Surgical Procedures; Pancreatic Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Experience of each group in robotic pancreatic surgery

  1 year

• Textbook outcome

  1 year

• Total survival

  3 years

• Disease-free survival

  3 years

Study Arms (4)

Duoneopancreatectomy

Resection of the head of the pancreas

Device: 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

Total pancreatectomy

Total removal of the pancreas

Device: robotic resection with Da Vinci Xi

central pancreatectomy

body or neck of the pancreas resection

Device: robotic resection with Da Vinci Xi

Interventions

robotic resection with Da Vinci Xi DEVICE

robotic resection with Da Vinci Xi

Distal pancreatectomy; Duoneopancreatectomy; Total pancreatectomy; central pancreatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo robotic pancreatic resections

You may qualify if:

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

You may not qualify if:

• Less than 18 years old.
• ASA IV

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share