跳至主要内容
临床试验/NCT05595811
NCT05595811已完成不适用

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

Rigshospitalet, Denmark0 个研究点目标入组 2,326 人开始时间: 1999年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,326
主要终点
waiting time from diagnosis to surgery

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
41 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

waiting time from diagnosis to surgery

时间窗: from 31. January 1999 to 31. January 2021

time from diagnosis to surgery for each patient

number and kind of postoperative complications

时间窗: 31. January 1999 to 31. January 2021

anastomosis leak, bleeding, death of any reason, in-hospital

overall survival

时间窗: 31. January 1999 to 31. January 2022

from operation to death of any course

次要结局

  • adjuvant oncologic treatment(31. January 1999 to 31. January 2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

carsten palnaes hansen

consultant

Rigshospitalet, Denmark

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