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

Sponsor
Jinling Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT05088304
Collaborator
Jiangsu Cancer Institute & Hospital (Other), Subei People's Hospital of Jiangsu Province (Other), Peking Union Medical College (Other)
205
34

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. postoperative complications [Within 60 days after surgery]

    postoperative complications (infectious complications and noninfectious complications)

Secondary Outcome Measures

  1. length of stay (LOS) [Within 60 days after surgery]

    length of stay (LOS)

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

    wound healing time

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

    postoperative antibiotic time

  4. nutritional status [up to 4 weeks]

    nutritional status ( such as: weight,albumin,prealbumin)

  5. hospitalization cost [Within 60 days after surgery]

    hospitalization cost(including: surgery and medicine costs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wang Xinying, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT05088304
Other Study ID Numbers:
  • JinlingHospital-1
  • 201502022
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wang Xinying, Professor, Jinling Hospital, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021