NCT06160154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,672

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 29, 2023

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intraoperative events

    Major bleeding or change in operation

    30 days

  • 30-day/in-hospital mortality.

    Dead in hospital or within 30 days

    30 days

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of HPB Surgery

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

December 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations