Division of Gastroenterology, McGill University, McGill University Health Centre, Montreal, QC, Canada. Division of Gastroenterology, Jewish General Hospital, McGill University, Montreal, QC, Canada. Division of Gastroenterology, McGill University, McGill University Health Centre, Montreal, QC, Canada; Department of Clinical Epidemiology, McGill University, McGill University Health Centre, Montreal, QC, Canada. Electronic address: email@example.com.
BACKGROUND AND AIMS TC-325, an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant gastrointestinal (GI) bleeding. The aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding. METHODS Adult patients presenting with
acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality. RESULTS A pre-planned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% female, age 67.2 +/- 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P = 0.057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P = 0.170). CONCLUSIONS This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding, and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding.