Diagnostic Consistency of the Global Leadership Initiative on Malnutrition (GLIM) Criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for Malnutrition in Patients With Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Diagnostic Consistency between GLIM Criteria and PG-SGA
Study Overview
Brief Summary
This study aimed to evaluate the diagnostic consistency between the Global Leadership Initiative on Malnutrition (GLIM) criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for identifying malnutrition in patients with pancreatic malignant tumors. The goal is to determine if the GLIM criteria, a newer and more streamlined tool, shows substantial agreement with the well-established PG-SGA, thereby supporting its use in this high-risk clinical population.
Detailed Description
Pancreatic cancer is a highly aggressive malignancy often associated with severe nutritional decline. While the Nutritional Risk Screening 2002 (NRS 2002) is used for initial screening and the Patient-Generated Subjective Global Assessment (PG-SGA) is a recognized standard for detailed nutritional assessment, the PG-SGA can be time-consuming. The Global Leadership Initiative on Malnutrition (GLIM) criteria were developed to provide a globally harmonized, two-step framework for diagnosing malnutrition. This prospective observational study was designed to compare the performance of GLIM criteria against the PG-SGA in patients with pancreatic cancer. Patients admitted to the hospital were screened with NRS 2002. Those at nutritional risk (NRS 2002 ≥ 3) were then comprehensively assessed using both PG-SGA and GLIM criteria. The study hypothesis is that the GLIM criteria and PG-SGA will demonstrate good consistency in diagnosing malnutrition in this population, validating GLIM as a practical and reliable assessment tool in clinical settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histopathologically confirmed pancreatic malignant tumor.
- •Age ≥ 18 years.
- •Clear cognition and ability to communicate verbally.
- •Nutritional Risk Screening 2002 (NRS 2002) score ≥
- •Provision of written informed consent to participate.
Exclusion Criteria
- •Presence of severe cardiac, hepatic, or renal comorbidities.
- •Bedridden status precluding weight measurement.
- •Contraindications to bioelectrical impedance analysis (e.g., implanted electronic devices, amputation).
- •Concurrent diagnosis of other malignant tumors, particularly of the digestive system.
- •Inability to cooperate with questionnaire completion or assessments.
Arms & Interventions
Nutritional Assessment Cohort
A single cohort of patients with pancreatic cancer and nutritional risk (NRS 2002 ≥ 3) who underwent comprehensive nutritional assessment using both the GLIM criteria and the PG-SGA to evaluate the diagnostic consistency between the two tools. All participants in this arm receive all listed diagnostic procedures.
Intervention: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment (Diagnostic Test)
Nutritional Assessment Cohort
A single cohort of patients with pancreatic cancer and nutritional risk (NRS 2002 ≥ 3) who underwent comprehensive nutritional assessment using both the GLIM criteria and the PG-SGA to evaluate the diagnostic consistency between the two tools. All participants in this arm receive all listed diagnostic procedures.
Intervention: Patient-Generated Subjective Global Assessment (PG-SGA) (Diagnostic Test)
Outcomes
Primary Outcomes
Diagnostic Consistency between GLIM Criteria and PG-SGA
Time Frame: Assessed once within 24 hours of hospital admission.
The consistency in diagnosing malnutrition (yes/no) between the GLIM criteria and the PG-SGA was assessed. The agreement was quantified using Cohen's kappa coefficient (κ). A kappa value of 0.61-0.80 was interpreted as substantial agreement.
Secondary Outcomes
- Prevalence of Malnutrition according to GLIM Criteria(Assessed once within 24 hours of hospital admission.)
- Prevalence of Malnutrition according to PG-SGA(Assessed once within 24 hours of hospital admission.)
- Correlation of Assessment Tools with Nutritional Indicators(Assessed at baseline (within 24 hours of admission).)
Investigators
Feifei Wang
Principal Investigator
The First Hospital of Hebei Medical University