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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02811666
Acronym
A15-10
Enrollment
200
Registered
2016-06-23
Start date
2016-11-30
Completion date
2019-11-30
Last updated
2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Malnutrition, Pancreatic Cancer, Sarcopenia

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.

Interventions

DEVICEAssessment of sarcopenia by CT-Scan
DEVICEhand gauge

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
muscle surface using CT-Scanup to12th month postoperatively
muscle strength using a hand gaugeup to12th month postoperatively

Countries

France

Contacts

Primary ContactYohann RENARD
yrenard@chu-reims.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026