Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

Pancreas Disease Clinical Trial

— E-MIPS  

Official title:

Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe: A Critical Appraisal of the First 3 Years of the E-MIPS Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135233
• Other study ID #: NP5626
• 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 MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were 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 MIPD in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (MIPD) are lacking.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1336
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Data from all patients who underwent R-MIPD and L-MIPD 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 pancreatic surgery, 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	Major morbidity		30 days
Primary	30-day/in-hospital mortality.		30 days