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

Hebei Medical University

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment; Diagnostic Test: Patient-Generated Subjective Global Assessment (PG-SGA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07057895

2022S00558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed pancreatic malignant tumor.
• Age ≥ 18 years.
• Clear cognition and ability to communicate verbally.
• Nutritional Risk Screening 2002 (NRS 2002) score ≥ 3.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Nutritional Assessment Cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Patient-Generated Subjective Global Assessment (PG-SGA)

Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment