Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry

Pancreas Disease Clinical Trial

Official title:

Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06160154
• Other study ID #: NP5627
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Description:

The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPS in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive distal pancreatectomy (MIDP) are lacking.

A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1672
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Data from all patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021 were included

Exclusion Criteria:

Other pancreatic procedures Hybrid approaches (reconstruction phase open) Procedures with insufficient baseline data / missing primary outcome data.

Related Conditions & MeSH terms

• Pancreas Disease
• Pancreatic Diseases

Intervention

Other:
• no intervention
all patients undergoing minimally invasive distal pancreatectomy, no intervention, no randomization

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative events	Major bleeding or change in operation	30 days
Primary	30-day/in-hospital mortality.	Dead in hospital or within 30 days	30 days