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

The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Muscle Loss; Cancer of Stomach; Cancer of Esophagus
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 205

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications (infectious complications and noninfectious complications)	Within 60 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay (LOS)	length of stay (LOS)	Within 60 days after surgery
wound healing time	wound healing time	Within 60 days after surgery
postoperative antibiotic time	postoperative antibiotic time	Within 60 days after surgery
nutritional status	nutritional status ( such as: weight，albumin，prealbumin)	up to 4 weeks
hospitalization cost	hospitalization cost(including: surgery and medicine costs)	Within 60 days after surgery

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Collaborators: Jiangsu Cancer Institute & Hospital; Peking Union Medical College; Subei People's Hospital of Jiangsu Province

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Postoperative complications; FFIM; GLIM
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Nutrition Disorders; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Malnutrition; Esophageal Neoplasms
• Other Study ID Numbers: JinlingHospital-1; 201502022 (Other Grant/Funding Number: Research Special Fund for Public Welfare Industry of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No