NCT07057895

Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment	Malnutrition was diagnosed according to the GLIM consensus criteria. This required at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation/disease burden). Reduced muscle mass was assessed by bioelectrical impedance analysis (BIA). The assessment was performed once for each patient within 24 hours of hospital admission.
DIAGNOSTIC_TEST	Patient-Generated Subjective Global Assessment (PG-SGA)	A comprehensive nutritional assessment administered by trained clinical staff. The tool comprises patient-reported sections (weight history, food intake, symptoms, activities/function) and clinician-assessed sections (disease, metabolic demand, physical exam). For this study, a total score of ≥2 was considered indicative of malnutrition. The assessment was performed once for each patient within 24 hours of hospital admission.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China