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


2016-11


2018-11


2019-11


200

Study Overview

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.

  • Sarcopenia
  • Malnutrition
  • Pancreatic Cancer
  • Liver Cancer
  • DEVICE: Assessment of sarcopenia by CT-Scan
  • DEVICE: hand gauge
  • PA16063

Study Record Dates

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  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Patients operated for liver or pancreas cancer

DEVICE: Assessment of sarcopenia by CT-Scan

DEVICE: hand gauge

Primary Outcome MeasuresMeasure DescriptionTime Frame
muscle surface using CT-Scanup to12th month postoperatively
muscle strength using a hand gaugeup to12th month postoperatively
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

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]

Participation Criteria

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:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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