Diagnostic performance of serum pepsinogen assay for the prediction of atrophic gastritis and gastric neoplasms: Protocol for a systematic review and meta-analysis

BACKGROUND: Serum pepsinogen assay (sPGA) combining concentration of pepsinogen I (PG I), and the ratio of PG I/II is the noninvasive biomarker for predicting chronic atrophic gastritis (CAG) and neoplasms reflecting mucosal secretory status. Although various cut-off values have been suggested, PG I ≤70 ng/mL and PG I/II ≤3 have been widely accepted. However, previous studies for diagnostic test accuracy presented only pooled outcomes, which cannot discriminate the diagnostic validity of sPGA with cut-off of PG I ≤70 ng/mL and PG I/II ≤3. METHODS: We will search the core databases [MEDLINE (through PubMed), the Cochrane Library, and Embase] from their inception to December 2018 by 2 independent evaluators. The P.I.C.O. is as follows; Patients: who have histologically proven CAG or gastric neoplasms, Intervention: sPGA with cut-off of PG I ≤70 ng/mL and/or PG I/II ≤3, Comparison: none, Outcome: diagnostic performance indices of sPGA for CAG and gastric neoplasms (sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) (if, true/false positive, true/false negative values are presented, diagnostic performance indices will be calculated). All types of study design with full text will be sought and included. The risk of bias will be assessed using the QUADAS-2 tool. Descriptive data synthesis is planned and quantitative synthesis (bivariate and HSROC model) will be used if the included studies are sufficiently homogenous. Publication bias will be assessed. RESULTS: The results will provide clinical evidence for diagnostic validity of sPGA. CONCLUSION: This study will provide evidence of sPGA for predicting CAG and gastric neoplasms.