Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers

Conditions
-----------------
Sarcopenia, Malnutrition, Pancreatic Cancer, Liver Cancer

Intervention / Treatment
-----------------
* Device: Assessment of sarcopenia by CT-Scan
* Device: hand gauge


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients operated for liver or pancreas cancer<br> | Device: Assessment of sarcopenia by CT-Scan<br> <br> Device: hand gauge<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle surface using CT-Scan |  | up to12th month postoperatively | 
| muscle strength using a hand gauge |  | up to12th month postoperatively |