Clinical trial NCT06381362: Italian Registry of Minimally Invasive Pancreatic Surgery
Official title: Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Surgery
Lead sponsor: Associazione Italiana per lo Studio del Pancreas
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will involve all patients undergoing at participating centers a pancreatic surgery performed by minimally invasive technique (e.g., laparoscopic, robotic), over the age of 18 years, capable of expressing consent to the study.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Underwent minimally invasive pancreatic surgery

Exclusion Criteria:

* Pregnant woman
* Minor or unable to give informed consent

Primary outcomes:
measure: Postoperative short-term outcomes
timeFrame: 90 days
measure: Long-term oncological outcomes
timeFrame: 2 years
Secondary outcomes:
measure: Rate of cases that after a minimally invasive approach had to be converted to and open approach
timeFrame: Intraoperative
measure: Surgeon learning curve
timeFrame: Intraoperative
measure: Surgeon learning curve
timeFrame: Intraoperative
measure: Surgeon learning curve
timeFrame: Intraoperative
measure: Surgeon learning curve
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Giovanni Capretti
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Alessandro Zerbi, Prof.
role: PRINCIPAL_INVESTIGATOR
References: