Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

NCT ID: NCT06135233

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreas Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention

all patients undergoing minimally invasive pancreatic surgery, no intervention, no randomization

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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M.G. Besselink

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, locatie AMC

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NP5626

Identifier Type: -

Identifier Source: org_study_id

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