Pancreatic Cancer Clinical Trial
Official title:
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
Sarcopenia (loss of muscle mass and function) can be observed at any age and results of
multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply
impacts the physical performance and the basal metabolism, and induces cardiovascular
disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor
decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing
mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on
postoperative course in digestive oncology. The search for sarcopenia, complementary
nutritional status, is now a source of great interest with 62 ongoing projects in the United
States.
The first objective of this study is to evaluate the impact of preoperative sarcopenia on
30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal
cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative
sarcopenia on the long term outcomes (12 months) on the same patients.
In this interventional, intent-to-treat, single-center cohort, prospective study, sarcopenia will be evaluated by the decrease in muscle surface (assessed by CT-Scan) associated with a decrease in muscle strength (assessed by hand gauge). Preoperative evaluation will also include nutritional status by physical examination and laboratory tests, and many nutritional questionnaires. The same data (including sarcopenia, laboratory tests and nutritional evaluation) will be collected at 7 days, 30 days and 12 months, as well as the morbidity and mortality. Statistical tests might evaluate if sarcopenia may be an independent factor of morbidity and mortality among these patients. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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