Pancreatic Ductal AdenocarcinomaNCT04802993
Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate
An observational study of Pancreatic Ductal Adenocarcinoma, run by Linkoeping University.
Trial summary
The primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Resection rates
- How many people
- 5,123 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 2 Oct 2020
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients registered in the Swedish National Registry for tumours in the pancreatic and periampullary region diagnosed with right-sided pancreatic adenocarcinoma or resected with pancreaticoduodenectomy
Who may be able to join
- Diagnosed between 1 January 2010 and 31 December 2018
- Registered in the Swedish National Registry for tumours in the pancreatic and periampullary region
- Either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy
Who cannot join
- None
About this study
Official title: Survival Among Elderly Patients in Sweden With Right-sided Pancreatic Adenocarcinoma Depending on Resection Rate of Pancreaticoduodenectomy
The primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Resection rates
- Keywords
- pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection ratesOther
All groups are divided into one high- and one low resection rate group depending on percentage of patients with pancreatic ductal adenocarcinoma resected per county and year (first three groups) and resection rate of pancreaticoduodenectomy per 100 000 inhabitants per county (last three groups)
| Study group | Role | What they receive |
|---|---|---|
| All patients with pancreatic ductal adenocarcinoma aged 70 years and older | All patients in the registry aged 70 years and older with right-sided pancreatic ductal adenocarcinoma Receives: Other: Resection rates | |
| All patients with pancreatic ductal adenocarcinoma aged 70-79 years | All patients in the registry aged 70-79 years with right-sided pancreatic ductal adenocarcinoma Receives: Other: Resection rates | |
| All patients with pancreatic ductal adenocarcinoma aged 80 years and older | All patients in the registry aged 80 years and older with right-sided pancreatic ductal adenocarcinoma Receives: Other: Resection rates | |
| All patients resected with pancreaticoduodenectomy, all ages | All patients in the registry resected with pancreaticoduodenectomy during the study period Receives: Other: Resection rates | |
| All patients resected with pancreaticoduodenectomy, aged 70-79 years | All patients in the registry resected with pancreaticoduodenectomy during the study period, aged 70-79 years Receives: Other: Resection rates | |
| All patients resected with pancreaticoduodenectomy, aged 80 years and older | All patients in the registry resected with pancreaticoduodenectomy during the study period, aged 80 years and older Receives: Other: Resection rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival among patients aged 70 years and over with pancreatic ductal adenocarcinoma in the pancreatic head
Measured: A little more than 10 years (from first patient to vital status)
Secondary outcomes (1)
Severe complications after pancreaticoduodenectomy
The rate of severe complications among patients aged 70 years and over who had undergone pancreaticoduodenectomy for any reason
Measured: Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2010
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Other
- Enrolment
- 5,123 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bergthor Björnsson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802993
- Sponsor's protocol ID
- 2017/151-31
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be further shared by the researchers but is available on application to the Swedish National Registry for tumours in the pancreatic and periampullary region, provided the application is approved by the Swedish Ethical Review Authority
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Among Elderly Patients in Sweden With Right-sided Pancreatic Adenocarcinoma Depending on Resection Rate of Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04802993
- Acronym / sponsor ID
- 2017/151-31
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,123 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 17 Mar 2021 (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 primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| All patients with pancreatic ductal adenocarcinoma aged 70 years and older | – | Other: Resection ratesAll patients in the registry aged 70 years and older with right-sided pancreatic ductal adenocarcinoma |
| All patients with pancreatic ductal adenocarcinoma aged 70-79 years | – | Other: Resection ratesAll patients in the registry aged 70-79 years with right-sided pancreatic ductal adenocarcinoma |
| All patients with pancreatic ductal adenocarcinoma aged 80 years and older | – | Other: Resection ratesAll patients in the registry aged 80 years and older with right-sided pancreatic ductal adenocarcinoma |
| All patients resected with pancreaticoduodenectomy, all ages | – | Other: Resection ratesAll patients in the registry resected with pancreaticoduodenectomy during the study period |
| All patients resected with pancreaticoduodenectomy, aged 70-79 years | – | Other: Resection ratesAll patients in the registry resected with pancreaticoduodenectomy during the study period, aged 70-79 years |
| All patients resected with pancreaticoduodenectomy, aged 80 years and older | – | Other: Resection ratesAll patients in the registry resected with pancreaticoduodenectomy during the study period, aged 80 years and older |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered in the Swedish National Registry for tumours in the pancreatic and periampullary region diagnosed with right-sided pancreatic adenocarcinoma or resected with pancreaticoduodenectomy
Key inclusion criteria (3 listed)
- Diagnosed between 1 January 2010 and 31 December 2018
- Registered in the Swedish National Registry for tumours in the pancreatic and periampullary region
- Either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection ratesAll groups are divided into one high- and one low resection rate group depending on percentage of patients with pancreatic ductal adenocarcinoma resected per county and year (first three groups) and resection rate of pancreaticoduodenectomy per 100 000 inhabitants per county (last three groups) | Other | All patients resected with pancreaticoduodenectomy, aged 70-79 years, All patients resected with pancreaticoduodenectomy, aged 80 years and older, All patients resected with pancreaticoduodenectomy, all ages, All patients with pancreatic ductal adenocarcinoma aged 70 years and older, All patients with pancreatic ductal adenocarcinoma aged 70-79 years, All patients with pancreatic ductal adenocarcinoma aged 80 years and older |
Primary outcome
Overall survival
Time frame: A little more than 10 years (from first patient to vital status)
Overall survival among patients aged 70 years and over with pancreatic ductal adenocarcinoma in the pancreatic head
1 secondary outcome
Severe complications after pancreaticoduodenectomy
Time frame: Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)
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 17 Mar 2021.
- Individual participant dataSharing planned: No. The data cannot be further shared by the researchers but is available on application to the Swedish National Registry for tumours in the pancreatic and periampullary region, provided the application is approved by the Swedish Ethical Review Authority
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Linkoeping University.
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 3 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 17 Mar 2021. 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?
Overall survival (time frame: A little more than 10 years (from first patient to vital status)). 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 17 Mar 2021.