- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04802993
Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate
15 mars 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
5123
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Övrig
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Severe complications after pancreaticoduodenectomy
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2010
Primärt slutförande (Faktisk)
2 oktober 2020
Avslutad studie (Faktisk)
2 oktober 2020
Studieregistreringsdatum
Först inskickad
15 mars 2021
Först inskickad som uppfyllde QC-kriterierna
15 mars 2021
Första postat (Faktisk)
17 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017/151-31
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .