TC-325 (HEMOSPRAYTM) versus Standard of Care in Managing Malignant Gastrointestinal Bleeding: A Pilot Randomized Clinical Trial: 2017 Category Award (GI Bleeding)

Introduction: Standard of care (SOC) in managing malignant gastrointestinal bleeding (GIB), including traditional endoscopic, radiological, surgical and radiotherapeutic approaches, is limited in hemostatic effectiveness. TC-325 is a novel endoscopic hemostatic powder that has shown promise in managing such patients. Methods: Adult patients were randomized at urgent endoscopy to TC-325 or SOC if they presented with upper or lower GIB and a known luminal GI malignancy confirmed to be the source of bleeding. The primary outcome was immediate hemostasis (absence of bleeding for at least 3 minutes after endoscopic therapy). Secondary outcomes included clinical rebleeding, transfusion use, ICU, LOS, additional treatment and mortality. Results: A pre-planned 20 patients were randomized to TC-325 or SOC (25% female, age 67.2±15.9 years, 2.9±1.7 comorbidities). Adopted research methods performed well in securing informed consent and measuring pertinent clinical outcomes. An initial source of bleeding was found in 85% of patients, with oozing noted in 95.0%. Immediate hemostasis was achieved in 90% (95%CI: 59.6;98.2) of patients treated initially with TC-325 versus 40% (16.8;68.7) in the SOC group. After failed immediate hemostasis with SOC, 83.3% (43.7; 97.0) of patients crossed over to TC-325, with hemostasis then being achieved at the index endoscopy in 80% (37.6;96.4) of these cross-overs. None of the TC-325 patients crossed over to SOC (the sole patient having failed TC-325 died of exsanguination at index gastroscopy from rupture of a malignant inferior mesenteric artery aneurysm before other endoscopic modalities could be attempted). Overall, hemostasis at index endoscopy was achieved in 87.7% (62.1;96.3) whether initial treatment with TC-325 or following SOC failure. Rebleeding was lower in the TC-325 group (22.2% (0;56.1)) compared to patients treated with SOC (60% (23.1;96.9)). Other outcomes are shown in table 1. Conclusion: This pilot trial is the first to assess TC-325 in malignant bleeding and demonstrates the feasibility of a larger randomized trial with regards to recruitment and adequate powering for hemostatic outcomes. Although this trial was not designed to seek statistically significant differences, the results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding both in achieving immediate hemostasis and decreased subsequent rebleeding compared to existing standard of care.Table: Table. Primary and secondary outcomes

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