NCT06381362

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Feb 2019Feb 2029

Study Start

First participant enrolled

February 28, 2019

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

10 years

First QC Date

March 13, 2024

Last Update Submit

April 22, 2024

Conditions

Pancreatic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

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

    Intraoperative

  • Surgeon learning curve

    Intraoperative

  • Surgeon learning curve

    Intraoperative

  • Surgeon learning curve

    Intraoperative

  • Surgeon learning curve

    Intraoperative

Interventions

Minimally invasive pancreatic surgeryPROCEDURE

Minimally invasive pancreatic surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Pregnant woman
  • Minor or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giovanni Capretti

Milan, Italy

RECRUITING

Study Officials

  • Alessandro Zerbi, Prof.

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Zerbi, Prof.

CONTACT

+390282245941alessandro.zerbi@hunimed.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

April 24, 2024

Study Start

February 28, 2019

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)