Pancreas DiseaseNCT06160154
Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry
An observational study of Pancreas Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Disease
- How many people
- 1,672 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021
Who may be able to join
- Data from all patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021 were included
Who cannot join
- Other pancreatic procedures Hybrid approaches (reconstruction phase open) Procedures with insufficient baseline data / missing primary outcome data.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105 AZ
About this study
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.
Read the 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 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
- Pancreas Disease
- Being tested
- no intervention
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
all patients undergoing minimally invasive distal pancreatectomy, no intervention, no randomization
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative events
Major bleeding or change in operation
Measured: 30 days
30-day/in-hospital mortality.
Dead in hospital or within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,672 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160154
- Sponsor's protocol ID
- NP5627
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38498397
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry
- ClinicalTrials.gov ID
- NCT06160154
- Acronym / sponsor ID
- NP5627
- Conditions
- Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,672 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021
Key inclusion criteria (1 listed)
- Data from all patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021 were included
Key exclusion criteria (1 listed)
- Other pancreatic procedures Hybrid approaches (reconstruction phase open) Procedures with insufficient baseline data / missing primary outcome data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionall patients undergoing minimally invasive distal pancreatectomy, no intervention, no randomization | Other | – |
Primary outcome
Intraoperative events
Time frame: 30 days
Major bleeding or change in operation
30-day/in-hospital mortality.
Time frame: 30 days
Dead in hospital or within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 38498397van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.