TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial

被引:43
作者
Chen, Yen-I [1 ]
Wyse, Jonathan [3 ]
Lu, Yidan [1 ]
Martel, Myriam [1 ]
Barkun, Alan N. [1 ,2 ]
机构
[1] McGill Univ, Div Gastroenterol, Montreal, PQ, Canada
[2] McGill Univ, Dept Clin Epidemiol, Montreal, PQ, Canada
[3] McGill Univ, McGill Univ Hlth Ctr, Div Gastroenterol, Jewish Gen Hosp, Montreal, PQ, Canada
关键词
ARGON PLASMA COAGULATION; ENDOSCOPIC HEMOSTASIS; PEPTIC-ULCER; MANAGEMENT; HEMOSPRAY; OUTCOMES; TUMORS; HEMORRHAGE; EXPERIENCE;
D O I
10.1016/j.gie.2019.08.005
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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.
引用
收藏
页码:321 / +
页数:9
相关论文
共 31 条
[1]   Argon beam plasma coagulation in the management of cancers of the esophagus and stomach [J].
Akhtar, K ;
Byrne, JP ;
Bancewicz, J ;
Attwood, SEA .
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2000, 14 (12) :1127-1130
[2]   Hemospray for treatment of acute bleeding due to upper gastrointestinal tumours [J].
Arena, Monica ;
Masci, Enzo ;
Eusebi, Leonardo Henry ;
Iabichino, Giuseppe ;
Mangiavillano, Benedetto ;
Viaggi, Paolo ;
Morandi, Elisabetta ;
Fanti, Lorella ;
Granata, Antonino ;
Traina, Mario ;
Testoni, Pier Alberto ;
Opocher, Enrico ;
Luigiano, Carmelo .
DIGESTIVE AND LIVER DISEASE, 2017, 49 (05) :514-517
[3]   Using Hemospray Improves the Cost-effectiveness Ratio in the Management of Upper Gastrointestinal Nonvariceal Bleeding [J].
Barkun, Alan N. ;
Adam, Viviane ;
Lu, Yidan ;
Chen, Yen-, I ;
Martel, Myriam .
JOURNAL OF CLINICAL GASTROENTEROLOGY, 2018, 52 (01) :36-44
[4]   Topical hemostatic agents: a systematic review with particular emphasis on endoscopic application in GI bleeding [J].
Barkun, Alan N. ;
Moosavi, Sarvee ;
Martel, Myriam .
GASTROINTESTINAL ENDOSCOPY, 2013, 77 (05) :692-700
[5]  
Chang YT, 2002, HEPATO-GASTROENTEROL, V49, P441
[6]  
Chen Yen-I, 2015, Gastrointest Endosc Clin N Am, V25, P535, DOI 10.1016/j.giec.2015.02.008
[7]   Hemostatic powder TC-325 in the management of upper and lower gastrointestinal bleeding: a two-year experience at a single institution [J].
Chen, Yen-I ;
Barkun, Alan ;
Nolan, Sabrina .
ENDOSCOPY, 2015, 47 (02) :167-171
[8]   Use of the endoscopically applied hemostatic powder TC-325 in cancer-related upper GI hemorrhage: preliminary experience (with video) [J].
Chen, Yen-I ;
Barkun, Alan N. ;
Soulellis, Constantine ;
Mayrand, Serge ;
Ghali, Peter .
GASTROINTESTINAL ENDOSCOPY, 2012, 75 (06) :1278-1281
[9]   Endoscopic hemostasis for bleeding gastric stromal tumors by application of hemoclip [J].
Cheng, AWK ;
Chiu, PWY ;
Chan, PCM ;
Lam, SH .
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES-PART A, 2004, 14 (03) :169-171
[10]  
Dutcher J P, 1987, Hematol Oncol Clin North Am, V1, P281