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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088304
• Other study ID #: JinlingHospital-1
• Secondary ID: 201502022
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2021
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer of Stomach
• Esophageal Neoplasms
• Malnutrition
• Muscle Loss
• Stomach Neoplasms

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	postoperative complications (infectious complications and noninfectious complications)	Within 60 days after surgery
Secondary	length of stay (LOS)	length of stay (LOS)	Within 60 days after surgery
Secondary	wound healing time	wound healing time	Within 60 days after surgery
Secondary	postoperative antibiotic time	postoperative antibiotic time	Within 60 days after surgery
Secondary	nutritional status	nutritional status ( such as: weight,albumin,prealbumin)	up to 4 weeks
Secondary	hospitalization cost	hospitalization cost(including: surgery and medicine costs)	Within 60 days after surgery