Pancreatic and Periampullary Tumors in Greenland Inuit

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05595811
• Other study ID #: RH-C-2022-1
• Status: Completed
• Start date: January 1, 1999
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2326
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms
• Periampullary Neoplasms

Intervention

Other:
• outcome following surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waiting time from diagnosis to surgery	time from diagnosis to surgery for each patient	from 31. January 1999 to 31. January 2021
Primary	number and kind of postoperative complications	anastomosis leak, bleeding, death of any reason, in-hospital	31. January 1999 to 31. January 2021
Primary	overall survival	from operation to death of any course	31. January 1999 to 31. January 2022
Secondary	adjuvant oncologic treatment	numbers treated	31. January 1999 to 31. January 2021