Italian Registry of Minimally Invasive Pancreatic Surgery
- Conditions
- Pancreatic Surgery
- Registration Number
- NCT06381362
- Lead Sponsor
- Associazione Italiana per lo Studio del Pancreas
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2300
- Age > 18 years;
- Underwent minimally invasive pancreatic surgery
- Pregnant woman
- Minor or unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative short-term outcomes 90 days any complication graded according to Clavien-Dindo classification
Long-term oncological outcomes 2 years Disease recurrence or disease related death
- Secondary Outcome Measures
Name Time Method Rate of cases that after a minimally invasive approach had to be converted to and open approach Intraoperative Intraoperative conversion to open surgery for any reason
Surgeon learning curve Intraoperative Variation of conversion rate according to the registered case-load as operating surgeon and first assistant
Trial Locations
- Locations (1)
Giovanni Capretti
🇮🇹Milan, Italy