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

NCT ID: NCT06160154

Last Updated: 2023-12-07

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

1672 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 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.

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 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.

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 distal pancreatectomy, no intervention, no randomization

Intervention Type OTHER

Eligibility Criteria

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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.
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 of HPB Surgery

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

References

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van Bodegraven EA, van Ramshorst TME, Bratlie SO, Kokkola A, Sparrelid E, Bjornsson B, Kleive D, Burgdorf SK, Dokmak S, Groot Koerkamp B, Cabus SS, Molenaar IQ, Boggi U, Busch OR, Petric M, Roeyen G, Hackert T, Lips DJ, D'Hondt M, Coolsen MME, Ferrari G, Tingstedt B, Serrablo A, Gaujoux S, Ramera M, Khatkov I, Ausania F, Souche R, Festen S, Berrevoet F, Keck T, Sutcliffe RP, Pando E, de Wilde RF, Aussilhou B, Krohn PS, Edwin B, Sandstrom P, Gilg S, Seppanen H, Vilhav C, Abu Hilal M, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Minimally invasive robot-assisted and laparoscopic distal pancreatectomy in a pan-European registry a retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3554-3561. doi: 10.1097/JS9.0000000000001315.

Reference Type DERIVED
PMID: 38498397 (View on PubMed)

Other Identifiers

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NP5627

Identifier Type: -

Identifier Source: org_study_id