TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial.
Gastrointest Endosc
; 91(2): 321-328.e1, 2020 02.
Article
en En
| MEDLINE
| ID: mdl-31437456
ABSTRACT
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 11 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. (Clinical trial registration number NCT02135627.).
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Hemostáticos
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Hemostasis Endoscópica
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Neoplasias Gastrointestinales
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Hemorragia Gastrointestinal
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Minerales
Tipo de estudio:
Clinical_trials
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Etiology_studies
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Gastrointest Endosc
Año:
2020
Tipo del documento:
Article
País de afiliación:
Canadá