Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate

March 15, 2021 updated by: 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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A little more than 10 years (from first patient to vital status)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

October 2, 2020

Study Completion (Actual)

October 2, 2020

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/151-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Ductal Adenocarcinoma

Clinical Trials on Resection rates

Subscribe