962 AN NON-INFERIORITY RANDOMIZED CONTROLLED TRIAL TO COMPARE HEMOSTATIC POWDER TC325 AND STANDARD THERAPY IN BLEEDING FROM NON-VARICEAL UPPER GASTROINTESTINAL CAUSES

Abstract

Observational studies suggest that endoscopic application of TC-325, a hemostatic powder can control active bleeding from non-variceal upper gastrointestinal causes. TC-325, as a monotherapy, has not been compared to standard treatment in a randomized controlled trial with adequate sample size. In this multicenter non-inferiority randomized controlled trial, we assigned patients actively bleeding from a non-variceal cause during esophago-gastro-duodenoscopy to receive either spraying with TC-325 or standard treatment. They were followed up for 30 days for further bleeding. A total of 224 patients were randomized (TC-325 N=111, standard treatment N=113). These include 130 gastroduodenal ulcers (58%), 32 tumors (14.3%) and 62 other causes (27.7%). With intention-to-treat analysis, the re-bleeding free probability over 30 days was 89.8% in the TC-325 group and 81.1% in the standard treatment group (difference in proportions, 95%CI; 8.7%, -1.3%, 18,7%). There were fewer failures in the control of bleeding during index endoscopy with the use of TC-325 (3 vs. 11, OR, 95%CI, 3.88, 1.05-14.32). Recurrent bleeding was similar between groups (9 vs. 10). There were 14 deaths to each group (P=0.96). Further interventions were similar (endoscopic treatment; 8 vs. 13, angiography 1 vs. 3) In patients with bleeding gastroduodenal ulcers, further bleeds occurred in 8 of 65, 12.5% in the TC-325 group and 10 of 65, 15.4% in the standard treatment group. The hemostatic powder, TC-325, is not inferior to standard treatment in the control of bleeding from non-variceal upper gastrointestinal causes. [Funded by the University Grant Council, the Hong Kong SAR Government]