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NCT Number: NCT06899269

SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Less than 18 years old.
  • ASA IV

Treatment and study plan

robotic resection with Da Vinci Xi

Device

robotic resection with Da Vinci Xi

Primary outcomes

  1. Postoperative complications

    Time frame: 90 postoperative days

    Clavien-Dindo Classification

  2. Postoperative complications

    Time frame: 90 postoperative days

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

  3. Number of robotic procedures

    Time frame: 1 year

    Number of robotic pancreatic procedures

Secondary outcomes

  1. Experience of each group in robotic pancreatic surgery

    Time frame: 1 year

    Questonnaire answering the number of robotic procedures in 2024.

  2. Textbook outcome

    Time frame: 1 year

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

  3. Total survival

    Time frame: 3 years

    survival after surgery in months

  4. Disease-free survival

    Time frame: 3 years

    Time from surgery to recurrence

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Alicante

Other

Registry information

Official study title

Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)

Acronym: SPAROBOPAN

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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