Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers (A15-10)

CHU de Reims

Status

Unknown

Conditions

Malnutrition

Liver Cancer

Sarcopenia

Pancreatic Cancer

Treatments

Device: hand gauge

Device: Assessment of sarcopenia by CT-Scan

Study type

Interventional

Funder types

Other

Identifiers

NCT02811666

PA16063

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients treated in the our digestive surgery department during the inclusion phase for the surgical curative treatment of liver (primary or secondary) and pancreatic cancer
Patients over 18 years
Patients who agreed to participate in the study
The patients insured by French health care

Exclusion criteria

Patients treated by radio-frequency
Patients operated for extrahepatic cholangiocarcinoma , cancer of the papilla of Vater or the gall-bladder
Patients with primary peritoneal cancer
Patients with palliative surgery without resection
Patients protected by law
Minor patients