Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers (A15-10)
Primary Purpose
Sarcopenia, Malnutrition, Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of sarcopenia by CT-Scan
hand gauge
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia
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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients operated for liver or pancreas cancer
Arm Description
Outcomes
Primary Outcome Measures
muscle surface using CT-Scan
muscle strength using a hand gauge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02811666
Brief Title
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
Acronym
A15-10
Official Title
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Malnutrition, Pancreatic Cancer, Liver Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients operated for liver or pancreas cancer
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Assessment of sarcopenia by CT-Scan
Intervention Type
Device
Intervention Name(s)
hand gauge
Primary Outcome Measure Information:
Title
muscle surface using CT-Scan
Time Frame
up to12th month postoperatively
Title
muscle strength using a hand gauge
Time Frame
up to12th month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yohann RENARD
Email
yrenard@chu-reims.fr
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohann RENARD
Email
yrenard@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
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