Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Surgery
• Intervention / Treatment: Procedure: Minimally invasive pancreatic surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 2300

Contacts and Locations

• Study Contact: Name: Alessandro Zerbi, Prof.; Phone Number: +390282245941; Email: alessandro.zerbi@hunimed.eu

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Giovanni Capretti
    • Contact: Giovanni Capretti, Dr.; Phone Number: +390282247646; Email: giovanni.capretti@hunimed.eu
    • Principal Investigator: Alessandro Zerbi, Prof.
    • Sub-Investigator: Giovanni Capretti, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant woman
• Minor or unable to give informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative short-term outcomes	any complication graded according to Clavien-Dindo classification	90 days
Long-term oncological outcomes	Disease recurrence or disease related death	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cases that after a minimally invasive approach had to be converted to and open approach	Intraoperative conversion to open surgery for any reason	Intraoperative
Surgeon learning curve	Variation of surgical time according to the registered case-load as operating surgeon and first assistant	Intraoperative
Surgeon learning curve	Variation of intraoperative blood-loss according to the registered case-load as operating surgeon and first assistant	Intraoperative
Surgeon learning curve	Variation of intraoperative complications rate according to the registered case-load as operating surgeon and first assistant	Intraoperative
Surgeon learning curve	Variation of conversion rate according to the registered case-load as operating surgeon and first assistant	Intraoperative

Collaborators and Investigators

• Sponsor: Associazione Italiana per lo Studio del Pancreas
• Investigators: Principal Investigator: Alessandro Zerbi, Prof., Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IGOMIPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No