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GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

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ClinicalTrials.gov Identifier: NCT05088304
Recruitment Status : Completed
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborators:
Jiangsu Cancer Institute & Hospital
Subei People's Hospital of Jiangsu Province
Peking Union Medical College
Information provided by (Responsible Party):
Wang Xinying, Jinling Hospital, China

Brief Summary:
The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

Condition or disease Intervention/treatment
Cancer of Stomach Cancer of Esophagus Malnutrition Muscle Loss Other: no intervention

Detailed Description:

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

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Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort Intervention/treatment
The normal FFMI group
The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female).
Other: no intervention
The low FFMI group
The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, </≥15 kg/m2 for females and </≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI <17 kg/m2 for male and FFMI <15 kg/m2 for female).
Other: no intervention



Primary Outcome Measures :
  1. postoperative complications [ Time Frame: Within 60 days after surgery ]
    postoperative complications (infectious complications and noninfectious complications)


Secondary Outcome Measures :
  1. length of stay (LOS) [ Time Frame: Within 60 days after surgery ]
    length of stay (LOS)

  2. wound healing time [ Time Frame: Within 60 days after surgery ]
    wound healing time

  3. postoperative antibiotic time [ Time Frame: Within 60 days after surgery ]
    postoperative antibiotic time

  4. nutritional status [ Time Frame: up to 4 weeks ]
    nutritional status ( such as: weight,albumin,prealbumin)

  5. hospitalization cost [ Time Frame: Within 60 days after surgery ]
    hospitalization cost(including: surgery and medicine costs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)
Criteria

Inclusion Criteria:

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.

Exclusion Criteria:

Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.

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Responsible Party: Wang Xinying, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT05088304    
Other Study ID Numbers: JinlingHospital-1
201502022 ( Other Grant/Funding Number: Research Special Fund for Public Welfare Industry of Health )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Xinying, Jinling Hospital, China:
FFIM
GLIM
Cancer
Postoperative complications
Additional relevant MeSH terms:
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Esophageal Neoplasms
Stomach Neoplasms
Malnutrition
Nutrition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases