Italian Registry of Minimally Invasive Pancreatic Surgery

Pancreatic Surgery Clinical Trial

— IGOMIPS  

Official title:

Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381362
• Other study ID #: IGOMIPS
• Status: Recruiting
• Start date: February 28, 2019
• Est. completion date: February 28, 2029

Study information

• Verified date: April 2024
• Source: Associazione Italiana per lo Studio del Pancreas
• Contact: Alessandro Zerbi, Prof.
• Phone: +390282245941
• Email: alessandro.zerbi[@]hunimed.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years;

• Underwent minimally invasive pancreatic surgery

Exclusion Criteria:

• Pregnant woman

• Minor or unable to give informed consent

Related Conditions & MeSH terms

• Pancreatic Surgery

Intervention

Procedure:
• Minimally invasive pancreatic surgery
Minimally invasive pancreatic surgery

Locations

Country	Name	City	State
Italy	Giovanni Capretti	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Italiana per lo Studio del Pancreas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative short-term outcomes	any complication graded according to Clavien-Dindo classification	90 days
Primary	Long-term oncological outcomes	Disease recurrence or disease related death	2 years
Secondary	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
Secondary	Surgeon learning curve	Variation of surgical time according to the registered case-load as operating surgeon and first assistant	Intraoperative
Secondary	Surgeon learning curve	Variation of intraoperative blood-loss according to the registered case-load as operating surgeon and first assistant	Intraoperative
Secondary	Surgeon learning curve	Variation of intraoperative complications rate according to the registered case-load as operating surgeon and first assistant	Intraoperative
Secondary	Surgeon learning curve	Variation of conversion rate according to the registered case-load as operating surgeon and first assistant	Intraoperative