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Clinical Trials/NCT02811666
NCT02811666
Unknown
Not Applicable

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

CHU de Reims1 site in 1 country200 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
CHU de Reims
Enrollment
200
Locations
1
Primary Endpoint
muscle surface using CT-Scan
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

muscle surface using CT-Scan

Time Frame: up to12th month postoperatively

muscle strength using a hand gauge

Time Frame: up to12th month postoperatively

Study Sites (1)

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