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Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers (A15-10)

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ClinicalTrials.gov Identifier: NCT02811666
Recruitment Status : Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Malnutrition Pancreatic Cancer Liver Cancer Device: Assessment of sarcopenia by CT-Scan Device: hand gauge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients operated for liver or pancreas cancer Device: Assessment of sarcopenia by CT-Scan
Device: hand gauge



Primary Outcome Measures :
  1. muscle surface using CT-Scan [ Time Frame: up to12th month postoperatively ]
  2. muscle strength using a hand gauge [ Time Frame: up to12th month postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811666


Contacts
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Contact: Yohann RENARD yrenard@chu-reims.fr

Locations
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France
Chu de Reims Not yet recruiting
Reims, France, 51092
Contact: Yohann RENARD       yrenard@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02811666     History of Changes
Other Study ID Numbers: PA16063
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Sarcopenia
Malnutrition
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms