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Completed

NCT Number: NCT06160154

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

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.

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Key information

Conditions

Pancreas Disease Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

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

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.

Treatment and study plan

No intervention

Other

all patients undergoing minimally invasive distal pancreatectomy, no intervention, no randomization

Primary outcomes

  1. Intraoperative events

    Time frame: 30 days

    Major bleeding or change in operation

  2. 30-day/in-hospital mortality.

    Time frame: 30 days

    Dead in hospital or within 30 days

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 7, 2023
Registry last updated
Dec 7, 2023

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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