Pancreatic CancerNCT06589102
Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery
An observational study of Pancreatic Cancer and Pancreatic Cyst, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The goal of this observational study is to investigate the role of lactate elevation. The main aims are: Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications Investigate what patient and surgical related factors that are associated with… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Cyst, Chronic Pancreatitis
- How many people
- 491 participants
- Where
- 1 siteSweden
- Study dates
- 28 Dec 2022to 30 Mar 2023
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients scheduled to undergo major pancreatic surgery in a tertiary university hospital during 2016-18
Who may be able to join
- Patients undergoing pancreatic surgery 2016-2018
Who cannot join
- Patients unable to undergo scheduled surgery
- Missing data in the postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to investigate the role of lactate elevation.
The main aims are:
- Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications
- Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.
- Conditions
- Pancreatic Cancer, Pancreatic Cyst, Chronic Pancreatitis
- Keywords
- Pancreatic surgery
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst, Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
hospital stay following surgery
Measured: All patients are followed until they leave the hospital, but a maximum of six months
Secondary outcomes (3)
General postoperative complications
Defined as Clavien-Dindo grade III-V
Measured: All patients are followed until they leave the hospital, but a maximum of six months
ICU care
Organ failure requiring ICU care
Measured: All patients are followed until they leave the hospital, but a maximum of six months
Surgery specific complications
Pancreatic fistula, bile leakage, delayed gastric emptying
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Dec 2022
- Primary completion30 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Grip, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589102
- Sponsor's protocol ID
- 2019-04284
- Other IDs
- 2019
- Status last verified
- Sep 2024
- First submitted
- 9 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT06589102
- Acronym / sponsor ID
- 2019-04284
- Conditions
- Pancreatic Cancer, Pancreatic Cyst, Chronic Pancreatitis
- Keywords
- Pancreatic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The goal of this observational study is to investigate the role of lactate elevation.
The main aims are:
- Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications
- Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients scheduled to undergo major pancreatic surgery in a tertiary university hospital during 2016-18
Key inclusion criteria (1 listed)
- Patients undergoing pancreatic surgery 2016-2018
Key exclusion criteria (2 listed)
- Patients unable to undergo scheduled surgery
- Missing data in the postoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital stay
Time frame: All patients are followed until they leave the hospital, but a maximum of six months
hospital stay following surgery
3 secondary outcomes
General postoperative complications
Time frame: All patients are followed until they leave the hospital, but a maximum of six months
ICU care
Time frame: All patients are followed until they leave the hospital, but a maximum of six months
Surgery specific complications
Time frame: 90 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 19 Sep 2024.
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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 Pancreatic Cancer and Pancreatic Cyst, run by Karolinska University Hospital at 1 site in Sweden.
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 2 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 19 Sep 2024. 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 Sweden. 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?
Length of hospital stay (time frame: All patients are followed until they leave the hospital, but a maximum of six months). 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 19 Sep 2024.