Abstract

The efficacy of topical hemostatic agents, recommended for peptic ulcer bleeding, remains poorly characterized in malignant gastrointestinal bleeding (GIB). We performed an individual patient data (IPD) meta-analysis assessing the efficacy of topical hemostatic agents in malignant GIB. The literature was searched using OVID MEDLINE, EMBASE, and ISI Web of Sciencedatabases (database inception to November 2023). Only randomized controlled trials (RCTs) comparing topical hemostatic agents to conventional endoscopic modalities in malignant GIB were included. Original RCT patient-level data were obtained. PRISMA guidelines were followed. Quality of the evidence was evaluated using the revised Cochrane risk of bias tool, and certainty of evidence with the GRADE approach. The primary outcome was immediate hemostasis; secondary outcomes were 30-day rebleeding and the composite measure of further bleeding (persistent bleeding or 30-day rebleeding). Other outcomes were all-cause mortality, adverse events, and need for additional non-endoscopic treatment. Odds ratios (ORs) from endpoint comparisons were pooled using logistic regression models. Overall, 985 citations were identified; 3 RCTs (n=160 patients) were included with all assessing TC-325 (Hemospray™). TC-325 achieved immediate hemostasis more often than conventional endoscopic modalities (OR=46.6 (5.89; 369.1)) (low level certainty). Thirty-day rebleeding (OR=0.28 (0.11; 0.70)) and further bleeding (OR=0.11 (0.05; 0.26)) were both significantly lower with TC-325 (very low level certainty). All-cause mortality and need for additional non-endoscopic treatment did not differ between groups. No adverse events were reported. Subgroup analysis confirmed TC-325 superiority in patients with upper GIB. TC-325 appears superior to conventional endoscopic therapy in managing patients with malignant GIB. TC-325 results in improvements in immediate hemostasis, 30-day rebleeding and further bleeding, based on very low-to-low certainties of evidence.

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