Patients Suspected for a Pancreatic (Pre-)MalignancyNCT02175992
Quality of Life After Surgery for Pancreatic Carcinoma
An observational study of Patients Suspected for a Pancreatic (Pre-)Malignancy, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Suspected for a Pancreatic (Pre-)Malignancy
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to 30 Jun 2017
- How long will I take part?
- 24 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a suspected pancreatic malignancy
Who may be able to join
- patients with a suspected pancreatic malignancy
- eligible for surgery with curative intent
- being able to complete questionnaires in Dutch
- age >=18 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Surgery, University Medical Center Utrecht
Utrecht, 3508 GA
About this study
Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
To assess the influence of pancreatic surgery for patients with a pancreatic malignancy on health-related quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startMar 2012
- Primary completion31 Dec 2016
- Study completion30 Jun 2017
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 Patients Suspected for a Pancreatic (Pre-)MalignancyStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. I.Q. Molenaar, MD, PhD, UMC Utrecht
- Investigators
- Quintus Molenaar, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175992
- Sponsor's protocol ID
- 13/546
- Status last verified
- May 2022
- First submitted
- 25 Jun 2014
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Heerkens HD, van Berkel L, Tseng DSJ, Monninkhof EM, van Santvoort HC, Hagendoorn J, Borel Rinkes IHM, Lips IM, Intven M, Molenaar IQ. Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications. HPB (Oxford). 2018 Feb;20(2):188-195. doi: 10.1016/j.hpb.2017.09.003. Epub 2017 Oct 29.
PubMed 29092792
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Surgery for Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT02175992
- Acronym / sponsor ID
- 13/546
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- 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.
Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a suspected pancreatic malignancy
Key inclusion criteria (4 listed)
- patients with a suspected pancreatic malignancy
- eligible for surgery with curative intent
- being able to complete questionnaires in Dutch
- age >=18 years
Key exclusion criteria (1 listed)
- none
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
Health-related quality of life
Time frame: 2 years
To assess the influence of pancreatic surgery for patients with a pancreatic malignancy on health-related quality of life
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 18 May 2022.
- Derived from this study: PubMed 29092792Heerkens HD, van Berkel L, Tseng DSJ, Monninkhof EM, van Santvoort HC, Hagendoorn J, Borel Rinkes IHM, Lips IM, Intven M, Molenaar IQ. Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications. HPB (Oxford). 2018 Feb;20(2):188-195. doi: 10.1016/j.hpb.2017.09.003. Epub 2017 Oct 29.
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.
Quintus Molenaar, MD PhD principal investigator
UMC Utrecht
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 Patients Suspected for a Pancreatic (Pre-)Malignancy, run by UMC Utrecht 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 4 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 18 May 2022. 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?
Health-related quality of life (time frame: 2 years). 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 NCT02175992, 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 18 May 2022.