- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04802993
Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate
15. mars 2021 oppdatert av: Bergthor Björnsson, Linkoeping University
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
5123
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Annen
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
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)
|
|
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
|
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)
|
|
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
|
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)
|
|
All patients resected with pancreaticoduodenectomy, all ages
All patients in the registry resected with pancreaticoduodenectomy during the study period
|
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)
|
|
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
|
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)
|
|
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
|
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 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
|
A little more than 10 years (from first patient to vital status)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Severe complications after pancreaticoduodenectomy
Tidsramme: Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)
|
The rate of severe complications among patients aged 70 years and over who had undergone pancreaticoduodenectomy for any reason
|
Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2010
Primær fullføring (Faktiske)
2. oktober 2020
Studiet fullført (Faktiske)
2. oktober 2020
Datoer for studieregistrering
Først innsendt
15. mars 2021
Først innsendt som oppfylte QC-kriteriene
15. mars 2021
Først lagt ut (Faktiske)
17. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2017/151-31
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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