Pancreatic NeoplasmsNCT04237441
The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT):
An observational study of Pancreatic Neoplasms, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. Read more about this study
- Who is it for?
- Ages 20 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- number of participants with surgical complications
- How many people
- 7,294 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2018
- 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 20 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all gender referred to MDT all gender not referred to MDT
Inclusion criteria: all gender seen at multidisciplinary team conference (MDT) Exclusion criteria: all gender not seen at MDT -
-
About this study
Official title: The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT): A Quality Improvement Study
Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.
Read the detailed description
Study is a retrospective register study from a prospective database over MDT conferences and patient outcome. End points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.
- Conditions
- Pancreatic Neoplasms
- Being tested
- number of participants with surgical complications
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
number of participants with surgical complicationsOther
Also called number of participants surviving months
observation before and after multidisplinary team conference (MDT) was implemented
| Study group | Role | What they receive |
|---|---|---|
| MDT conference | participants evaluated at MDT conference Receives: Other: number of participants with surgical complications | |
| no MDT conference | participants not evaluated at MDT conference Receives: Other: number of participants with surgical complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications following pancreatic surgery
study from clinical database
Measured: 14 years
survival following pancreatic surgery
study from clinical database
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 7,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, carsten palnaes hansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- carsten hansen, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237441
- Sponsor's protocol ID
- RH 2015-07, nr. 03616
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT): A Quality Improvement Study
- ClinicalTrials.gov ID
- NCT04237441
- Acronym / sponsor ID
- RH 2015-07, nr. 03616
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,294 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Jan 2020 (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.
Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.
Detailed description
Study is a retrospective register study from a prospective database over MDT conferences and patient outcome. End points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDT conference | – | Other: number of participants with surgical complicationsparticipants evaluated at MDT conference |
| no MDT conference | – | Other: number of participants with surgical complicationsparticipants not evaluated at MDT conference |
Who may qualify
- Ages
- 20 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all gender referred to MDT all gender not referred to MDT
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 |
|---|---|---|
| number of participants with surgical complicationsAlso: number of participants surviving monthsobservation before and after multidisplinary team conference (MDT) was implemented | Other | MDT conference, no MDT conference |
Primary outcome
complications following pancreatic surgery
Time frame: 14 years
study from clinical database
survival following pancreatic surgery
Time frame: 14 years
study from clinical database
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 30 Nov 2023.
- 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.
carsten hansen, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
complications following pancreatic surgery (time frame: 14 years). 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?
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 30 Nov 2023.