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

Completed

• Conditions: Cancer of Esophagus; Cancer of Stomach; Malnutrition; Muscle Loss
• Interventions: Other: no intervention

• Registration Number: NCT05088304
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-09-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01
• Study First Submitted: 2021-09-20
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The normal FFMI group	no intervention	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).
The low FFMI group	no intervention	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).

Primary Outcome Measures

Name	Time	Method
postoperative complications	Within 60 days after surgery	postoperative complications (infectious complications and noninfectious complications)

Secondary Outcome Measures

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