Pancreatic and Periampullary Tumors in Greenland Inuit

November 26, 2023 updated by: carsten palnaes hansen, Rigshospitalet, Denmark

The Outcome After Operation for Pancreatic and Periampullary Tumors in Greeland Inuit.

Especially since the Second World War the indigenous population in the Arctic, the Inuit have gone through a Westernization, which has improved the health conditions but also changed the disease panorama with an increasing incidence of cancer. This is exemplified by a decrease in physical activity, due to the depletion of the Greenlandic hunting traditions, tobacco smoking and unhealthy diet. At the beginning of the westernization, malignant diseases were highly uncommon, but they started to increase due to the increasing life expectancy and changes in lifestyle. The incidence of pancreatic and periampullary cancer has been reported to be the same among Inuit in Canada, Denmark, and the United States but with a higher incidence than among the Caucasian population in the three countries.

The aim with this study was to investigate the results of pancreatic surgery for pancreatic and periampullary tumors in Inuit patients in Greenland at to compare the outcome of surgery and the overall survival with a cohort of Danish patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design. The study is a retrospective, descriptive register study based on data from a prospectively maintained database. The study is a comparison of two cohorts, all Inuit patients living in Greenland, who had pancreatic operations for pancreatic and periampullary tumors - either preoperatively verified or suspected - at Rigshospitalet, Copenhagen University Hospital from 31. January 1999 to 31. January 2021. Danish patients living in Greenland were not included in the study. Inuit patients were compared with a cohort of Danish patients with same diagnosis and same range of age operated during the same period at the hospital. All diagnoses were histologically verified. Data recruitment include all patients operated between January 31, 1999 and January 31, 2021 with follow-up until December 31 after which data will be evaluated. The study is reported according to the STROCSS guidelines (www.strocssguideline.com).

Study population. The study includes 2326 consecutive patients, 47 inuit and 2279 Danish patients between 41 and 79 years (age range based on the inuit patients). There are 1,208 patients with malignant tumours of whom 1,020 have adenocarcinoma.

Data collection Data are collected from our prospectively maintained database of pancreatic operations, from the electronic hospital record systems Orbit and EPIC, the Danish National Pathology Data Registry, and from the National Register of Death. All Danish Nationals including citizens in Greenland have a unique Central Person Registration number that enables searching of health data.

Outcomes. Relevant postoperative complications are recorded in the study and include leakage from the pancreatic, bile or gastrojejunal anastomosis, intraabdominal hemorrhage and abscess formation or other complications with severe or fatal outcome. Outcomes are defined as postoperative complications and mortality assessed during 30- and 90-days and overall survival (OS) defined as the time from surgery to death from any cause or censoring at time of last follow-up. Hospitalization is defined as postoperative stay until discharge. In-hospital mortality is defined as all deaths from time of admission until discharge. Cancer specific mortality is defined as death from adenocarcinoma after other causes are censured.

Statistics. Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and are analyzed with Fisher's exact test. Non-parametric continuous data between subgroups are analyzed with the Mann-Whitney test. The Kaplan-Meier method and the cumulative incidence function with correction for competing risks are used to estimate OS and the log-rank test to examine the differences between curves. The reference population is an age and sex matched Danish standard population. A p < 0.05 is considered statistically significant. Statistical analysis is performed with GraphPad Prism software version 6.05. (GraphPad, La Jolla, CA).

Ethics. The study is a descriptive study and conducted in accordance with the principles stated in the Declaration of Helsinki. No approval is required according to the Danish National Health Board. The study is an observational, retrospective quality assurance project according to the guidelines of the Danish Health Data Authority (http://Sundhedsdatastyrelsen.dk). No approval is required according to the Danish National Health Board. In this respect it has to be noticed that a major part of the Greenlandic and Danish patients had died before the study was initiated, and the Regional Ethical Committee of the Capital Region of Denmark provided exemption for the study. The use of register data follows the General Data Protection Regulation of the European Union and the Danish Data Protection Agency. Patients' written consent for using health data was obtained before operation. The study and the use of data were consented by the hospital ethical

Study Type

Observational

Enrollment (Actual)

2326

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

39 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Greenland Inuit, both sex, living in Greenland and operated at Copenhagen University Hospital Rigshospitalet Danish patients (controls), both sex living in Denmark and operated at Copenhagen University Hospital Rigshospitalet

Description

Inclusion Criteria:

  • Greenland Inuit patients
  • operated for pancreatic and periampullary cancer
  • time of operation 31. January 1999 to 31. January 2021
  • sex: all
  • minimum age: 41 years
  • maximum years: 79 years

Exclusion Criteria

  • patients beyond the age limit
  • patients operated beyond the time limit

Danish patients

  • operated for pancreatic and periampullary cancer
  • time of operation 31. January 1999 to 31. January 2021
  • sex: all
  • minimum age: 41 years
  • maximum years: 79 years

Exclusion Criteria: patients beyond the age limit.

  • patients beyond the age limit.
  • time of operation 31. January 1999 to 31. January 2021

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inuit
Inuit living in Greenland
Other: outcome following surgery
Danish
Danish patients living in Denmark
Other: outcome following surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
waiting time from diagnosis to surgery
Time Frame: from 31. January 1999 to 31. January 2021
time from diagnosis to surgery for each patient
from 31. January 1999 to 31. January 2021
number and kind of postoperative complications
Time Frame: 31. January 1999 to 31. January 2021
anastomosis leak, bleeding, death of any reason, in-hospital
31. January 1999 to 31. January 2021
overall survival
Time Frame: 31. January 1999 to 31. January 2022
from operation to death of any course
31. January 1999 to 31. January 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adjuvant oncologic treatment
Time Frame: 31. January 1999 to 31. January 2021
numbers treated
31. January 1999 to 31. January 2021

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: carsten p hansen, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 1999

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-C-2022-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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 Neoplasms

Clinical Trials on outcome following surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe