Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial

Abstract

Background & aims: Current guidelines vary as to their recommendations addressing the role of hemostatic powders when managing patients with malignant gastrointestinal (GI) bleeding because these are based on very-low- to low-quality evidence, in large part due to a paucity of randomized trial data.

Methods: This was a patient- and outcome assessor-blinded, multicenter, randomized controlled trial. Patients presenting with active bleeding from an upper or lower GI lesion suspected to be malignant at index endoscopy between June 2019 and January 2022 were randomly allocated to receive either TC-325 alone or standard endoscopic treatment (SET). The primary outcome was 30-day rebleeding, and secondary objectives included immediate hemostasis and other clinically relevant endpoints.

Results: Overall, 106 patients made up the study population (55 TC-325 and 51 SET, after 1 exclusion in the TC-325 group and 5 in the SET group). Baseline characteristics and endoscopic findings did not differ between the groups. Thirty-day rebleeding was significantly lower in the TC-325 (2.1% TC-325 vs 21.3% SET; odds ratio, 0.09; 95% confidence interval [CI], 0.01-0.80; P = .003). Immediate hemostasis rates were 100% in the TC-325 group vs 68.6% in the SET group (odds ratio, 1.45; 95% CI, 0.93-2.29; P < .001). Other secondary outcomes did not differ between the 2 groups. Independent predictors of 6-month survival included the Charlson comorbidity index (hazard ratio, 1.17; 95% CI, 1.05-1.32; P = .007) and receiving an additional nonendoscopic hemostatic or oncologic treatment during 30 days after the index endoscopy (hazard ratio, 0.16; 95% CI, 0.06-0.43; P < .001) after adjustment for functional status, Glasgow-Blatchford score, and an upper GI source of bleeding.

Conclusion: The TC-325 hemostatic powder results in greater immediate hemostasis rates followed by lower 30-day rebleeding rates when compared to contemporary SET. (ClinicalTrials.gov, Number: NCT03855904).

Keywords: Gastrointestinal Bleeding; Hemostatic Powder; Tumor.