NCT06135233

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,336

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 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 13, 2023

Last Update Submit

November 16, 2023

Conditions

Pancreas Disease

Keywords

registryminimally invasive surgeryrobot-assistedlaparoscopypancreatoduodenectomypancreatic surgery

Outcome Measures

Primary Outcomes (2)

  • Major morbidity

    30 days

  • 30-day/in-hospital mortality.

    30 days

Interventions

No interventionOTHER

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

Eligibility Criteria

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

Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included

You may qualify if:

  • \- Data from all patients who underwent R-MIPD and L-MIPD 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

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

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)