2016-11
2018-11
2019-11
200
NCT02811666
CHU de Reims
CHU de Reims
INTERVENTIONAL
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2016-06-17 | N/A | 2016-06-21 |
2016-06-21 | N/A | 2016-06-23 |
2016-06-23 | N/A | 2016-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Patients operated for liver or pancreas cancer | DEVICE: Assessment of sarcopenia by CT-Scan DEVICE: hand gauge |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
muscle surface using CT-Scan | up to12th month postoperatively | |
muscle strength using a hand gauge | up to12th month postoperatively |
Secondary Outcome Measures | Measure Description | Time Frame |
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This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Yohann RENARD Phone Number: Email: [email protected] |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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