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

Pancreatic Cancer Clinical Trial

— A15-10  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02811666
• Other study ID #: PA16063
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 21, 2016
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: June 2016
• Source: CHU de Reims
• Contact: Yohann RENARD
• Email: yrenard[@]chu-reims.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Cancer
• Malnutrition
• Pancreatic Cancer
• Pancreatic Neoplasms
• Sarcopenia

Intervention

Device:
• Assessment of sarcopenia by CT-Scan

• hand gauge

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle surface using CT-Scan		up to12th month postoperatively	No
Primary	muscle strength using a hand gauge		up to12th month postoperatively	No