E-MIPS: Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Completed
• CT.gov ID: NCT06135233
• Collaborator: (none)
• Enrollment: 1,336
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 37.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Disease	Other: No intervention

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1336 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe: A Critical Appraisal of the First 3 Years of the E-MIPS Registry
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jan 1, 2022

Outcome Measures

Primary Outcome Measures

1. Major morbidity [30 days]

2. 30-day/in-hospital mortality. [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland	Netherlands	1105 AZ

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M.G. Besselink, professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT06135233
• Other Study ID Numbers: NP5626
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by M.G. Besselink, professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): registry; minimally invasive surgery; robot-assisted; laparoscopy; pancreatoduodenectomy; pancreatic surgery
• Additional relevant MeSH terms: Pancreatic Diseases

Study Results

No Results Posted as of Nov 18, 2023