NCT05088304

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

September 20, 2021

Last Update Submit

October 10, 2021

Conditions

Cancer of StomachCancer of EsophagusMalnutritionMuscle Loss

Keywords

FFIMGLIMCancerPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    postoperative complications (infectious complications and noninfectious complications)

    Within 60 days after surgery

Secondary Outcomes (5)

  • length of stay (LOS)

    Within 60 days after surgery

  • wound healing time

    Within 60 days after surgery

  • postoperative antibiotic time

    Within 60 days after surgery

  • nutritional status

    up to 4 weeks

  • hospitalization cost

    Within 60 days after surgery

Study Arms (2)

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

Interventions

no interventionOTHER
The low FFMI groupThe normal FFMI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsMalnutritionMuscular AtrophyNeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesNutrition DisordersNutritional and Metabolic DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 21, 2021

Study Start

September 1, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

October 21, 2021

Record last verified: 2021-10