NCT04802993

Brief 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. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,123

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

10.8 years

First QC Date

March 15, 2021

Last Update Submit

March 15, 2021

Conditions

Keywords

pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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)

Secondary Outcomes (1)

  • Severe complications after pancreaticoduodenectomy

    Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)

Study Arms (6)

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

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

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

Other: Resection rates

All patients resected with pancreaticoduodenectomy, all ages

All patients in the registry resected with pancreaticoduodenectomy during the study period

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

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

Other: Resection rates

Interventions

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 yearsAll patients resected with pancreaticoduodenectomy, aged 80 years and olderAll patients resected with pancreaticoduodenectomy, all agesAll patients with pancreatic ductal adenocarcinoma aged 70 years and olderAll patients with pancreatic ductal adenocarcinoma aged 70-79 yearsAll patients with pancreatic ductal adenocarcinoma aged 80 years and older

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor, senior consultant

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 17, 2021

Study Start

January 1, 2010

Primary Completion

October 2, 2020

Study Completion

October 2, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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