Italian Registry of Minimally Invasive Pancreatic Surgery

NCT ID: NCT06381362

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2029-02-28

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.

Conditions

Pancreatic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Minimally invasive pancreatic surgery

Minimally invasive pancreatic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant woman
• Minor or unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associazione Italiana per lo Studio del Pancreas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Zerbi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

Giovanni Capretti

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Zerbi, Prof.

Role: CONTACT

alessandro.zerbi@hunimed.eu

+390282245941

Facility Contacts

Giovanni Capretti, Dr.

Role: primary

giovanni.capretti@hunimed.eu

+390282247646

Other Identifiers

IGOMIPS

Identifier Type: -

Identifier Source: org_study_id