期刊
GASTROINTESTINAL ENDOSCOPY
卷 91, 期 2, 页码 321-+出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.gie.2019.08.005
关键词
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资金
- Pharmascience
- AtGen
- American Society for Gastrointestinal Endoscopy Endoscopic Award Committee
Background and Aims: TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our 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 preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, 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 = .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 = .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.
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