Pancreatic Surgery in Elderly Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      Pancreatic cancer is mainly seen among elderly subjects as more than 85 % of all patients are
      diagnosed after 60 years of age. Pancreatic surgery in the elderly is usually well tolerated,
      and the postoperative mortality has decreased and today is less than 5 % in high-volume
      centers. When offering an old patient pancreatic surgery for a malignant disease it is
      important to evaluate not only the probability that the patient may survive the operation,
      but also the relevance of an operation in relation to the patient's remnant life expectancy
      and other treatment options than surgery. This problem has not been addressed in most studies
      on pancreatic surgery in the elderly, in which the outcome after surgery was the end point.
      The endpoints of the present study are the post-operative survival and surgical complications
      after major pancreatic surgery in all patients operated in the study period, and the
      long-term survival of patients operated for adenocarcinomas. These endpoints were set from
      the assumption that the postoperative mortality is related to age and comorbidity, while the
      long-term survival is influenced by the primary disease.
    

Detailed description: 
      Study design The study is a retrospective, descriptive register study based on data from a
      prospectively maintained database. Data recruitment include all patients from the age of 18
      with adenocarcinoma in the pancreas, papilla of vater and duodenum operated between January
      1, 2010 and December 31, 2019 with a minimum of one year post-operative follow-up. Study
      completion date will be December 31, 2020. Patients are divided into two cohorts, patients
      younger than 75 years and patients 75 years and older. Moreover, data are divided into
      patients with malignant and non-malignant tumors. The study is reported according to the
      STROCSS guidelines (www.strocssguideline.com).

      Study population The study includes 1,556 consecutive patients, 1,296 patients between 18 and
      75 years and 260 patients aged 75 years and older. There are 1,208 patients with malignant
      tumours of whom 1,020 have adenocarcinoma. The remaining 348 patients have benign or no
      pathologic findings but were operated for pre-malignant diseases or on suspicion of a
      malignant tumor.

      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 have a
      unique Central Person Registration number that enables searching of health data. Patients
      from the Faroe Islands and Greenland are excluded, as they are not recorded in the Danish
      death register.

      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.
      Recorded years of life lost are defined as lost years compared to the expected remnant life
      of an age-matched standard population. The recorded years of life lost are the number of
      deprived years that could have been saved, if patient had not developed an event that had
      shortened life.

      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
      expected years of life lost are calculated as the difference between the area under the
      survival curve of the reference population and the patient population. 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 use of register data follows the General Data Protection
      Regulation of the European Union and is approved by the Danish Data Protection Agency (RH
      -2015-07, nr. 03616) and patients' consent. Consent for using health data was obtained before
      operation.
    

Intervention name(s): observational study
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Danish population operated for pancreatic tumors including ductal adenocarcinoma
      
Keywords: pancreatic cancer, surgery, old patients