S1403 Hemostatic Powders Are Equivalent to Standard Therapy in Benign Upper GI Bleeding and Superior in Tumor-Related Bleeding: A Systematic Review and Meta-Analysis

Introduction: Despite advances in methods of controlling active non-variceal upper gastrointestinal bleeding (UGIB), approximately 10%-20% of patients treated require repeat endoscopy within 48 hours due to persistent bleeding and/or rebleeding after initial hemostasis. Contact-free mineral hemostatic powders can be deployed in seconds and might circumvent technical failures, yet their aggregate efficacy and whether it varies by bleed etiology remains unclear. We therefore pooled all contemporary randomized trials, stratifying a priori into benign non-variceal versus tumor-related UGIB, to clarify where powders add value. Methods: A systematic search of PubMed, Embase, Scopus, and Cochrane Library identified randomized controlled trials (RCTs) comparing hemostatic powder to standard therapy in upper GI bleed and malignant bleed through May 2025. Data were analyzed using RevMan 4.2.1. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using Mantel-Haenszel methods. Random- or fixed-effects models were applied based on heterogeneity (Higgins’ I²). Statistical significance was set at P < 0.05. Risk of bias was assessed using RoB 2.0. Results: Across 255 benign NVUGIB episodes (Baracat 2019 + Jung 2023) topical powder achieved immediate haemostasis in 90% vs 87% with guideline therapy (RR 1.04, 95% CI 0.95–1.13; I² =0%) and the 30-day re-bleed rate was identical (10% vs 10%; RR 1.08, 0.52–2.23; I² = 0%).In sharp contrast, the 111-patient malignant-bleeding RCT showed 100% first-pass hemostasis versus 69% (RR 1.45, 1.20–1.75) and cut re-bleeding from 22% to 6% (RR 0.26, 0.08–0.80), yielding an absolute risk reduction of 16% and NNT = 6. Interaction testing confirmed significant effect-modification between subgroups for both hemostasis (χ² = 10.2, P = 0.001) and re-bleeding (χ² = 4.3, P = 0.04), fully accounting for the overall heterogeneity (I² 82% and 61%, respectively). Thirty-day mortality was low and comparable (11/179 vs 8/182; RR 1.35, 0.58–3.14). Conclusion: Topical powder therapy proved non-inferior to standard care in routine peptic-ulcer bleeding but reduced tumor-bleed re-bleeding by 74% (NNT = 6), with zero formulation-related adverse events. The dramatic oncologic benefit and equivalent benign performance position TC-325 as a high-value first-line option whenever malignancy underlies hemorrhage, while remaining a safe alternative in benign disease. Future multicenter RCTs should target malignancy-specific algorithms.