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Recruiting NCT06381362

Italian Registry of Minimally Invasive Pancreatic Surgery

Observational Pancreatic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally invasive pancreatic surgery.
Who it may be relevant to
Registry conditions: Pancreatic Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

Overview

Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes

Detailed description

Since 1994, when the first pancreatectomy surgeries, distal and proximal, conducted minimally invasively, were published, efforts have been made to understand the value of this approach in the context of a surgery as complex and burdened with specific complications as pancreatic surgery. The adoption of such an approach with regard to pancreatic surgery has been less rapid and parceled out than in other surgical fields and not supported by a large body of scientific publications. However, worldwide, referral centers for pancreatic surgery routinely use the minimally invasive approach in selected cases, and its diffusion has recently shown a marked increase. Even in Italy, a recent survey promoted by some of the major surgical societies showed a fair diffusion of the use of the minimally invasive approach in pancreatic surgery but with extremely variable ways and uses in the different territorial realities with evident and potentially risky paradoxes. Monitoring the diffusion of minimally invasive pancreatic surgery, the methods of application and the results of this approach has become of primary importance and for this reason the foundation of a national registry has been proposed by several scientific surgical societies.

This study aims to investigate what is the real diffusion of minimally invasive techniques in Italy and what postoperative outcomes the adoption of this approach generates.

Interventions

  • Procedure Minimally invasive pancreatic surgery
    Minimally invasive pancreatic surgery

Primary outcome measures

  • Postoperative short-term outcomes [Time frame: 90 days]
  • Long-term oncological outcomes [Time frame: 2 years]
Secondary outcome measures (5)
  • Rate of cases that after a minimally invasive approach had to be converted to and open approach [Time frame: Intraoperative]
  • Surgeon learning curve [Time frame: Intraoperative]
  • Surgeon learning curve [Time frame: Intraoperative]
  • Surgeon learning curve [Time frame: Intraoperative]
  • Surgeon learning curve [Time frame: Intraoperative]

Eligibility criteria

Inclusion criteria

  • Age > 18 years;
  • Underwent minimally invasive pancreatic surgery

Exclusion criteria

  • Pregnant woman
  • Minor or unable to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Giovanni Capretti — Milan

Identifiers

NCT: NCT06381362 · IGOMIPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗