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NCT Number: NCT06381362

Italian Registry of Minimally Invasive Pancreatic Surgery

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Giovanni Capretti

Milan, Italy

Location status: Recruiting

Location contact

Alessandro Zerbi, Prof.

PRINCIPAL_INVESTIGATOR

Giovanni Capretti, Dr.

CONTACT

[email protected]

+390282247646

Giovanni Capretti, Dr.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant woman
  • Minor or unable to give informed consent

Treatment and study plan

Minimally invasive pancreatic surgery

Procedure

Minimally invasive pancreatic surgery

Primary outcomes

  1. Postoperative short-term outcomes

    Time frame: 90 days

    any complication graded according to Clavien-Dindo classification

  2. Long-term oncological outcomes

    Time frame: 2 years

    Disease recurrence or disease related death

Secondary outcomes

  1. Rate of cases that after a minimally invasive approach had to be converted to and open approach

    Time frame: Intraoperative

    Intraoperative conversion to open surgery for any reason

  2. Surgeon learning curve

    Time frame: Intraoperative

    Variation of surgical time according to the registered case-load as operating surgeon and first assistant

  3. Surgeon learning curve

    Time frame: Intraoperative

    Variation of intraoperative blood-loss according to the registered case-load as operating surgeon and first assistant

  4. Surgeon learning curve

    Time frame: Intraoperative

    Variation of intraoperative complications rate according to the registered case-load as operating surgeon and first assistant

  5. Surgeon learning curve

    Time frame: Intraoperative

    Variation of conversion rate according to the registered case-load as operating surgeon and first assistant

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Zerbi, Prof.

CONTACT

[email protected]

+390282245941

Sponsors and collaborators

Lead sponsor

Associazione Italiana per lo Studio del Pancreas

Other

Registry information

Official study title

Italian Registry of Minimally Invasive Pancreatic Surgery (IGOMIPS)

Acronym: IGOMIPS

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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