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

Chen, Yen-I; Wyse, Jonathan; Lu, Yidan; Martel, Myriam; Barkun, Alan N.

doi:10.1016/j.gie.2019.08.005

Cited by 49 publications

(58 citation statements)

References 27 publications

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“…Accordingly, there is need for a noble, effective endoscopic hemostatic modality for tumor bleeding. In the present study, UI-EWD was found to have an excellent immediate hemostasis success rate, which is in accord with previous findings [ 10 , 24 ]. This high success rate can be explained by the hydrogel nature of UI-EWD.…”

Section: Discussionsupporting

confidence: 93%

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Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding

et al. 2021

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Background Gastrointestinal tumor bleeding remains a clinical challenge because it is difficult to treat with conventional endoscopic hemostatic options. Recently, an endoscopic hemostatic powder (UI-EWD) was developed and reported to provide effective control of upper gastrointestinal bleeding. The aim of current study was to evaluate the feasibility and efficacy of this novel hemostatic powder in tumor bleeding. Methods A total of 41 consecutive patients with upper gastrointestinal tumor bleeding were included. UI-EWD was applied in all patients as an auxiliary hemostatic method as a salvage therapy or monotherapy during endoscopic treatment. Hemostasis success rates, adverse event related to UI-EWD, and rates of re-bleeding were evaluated. Results In all cases, UI-EWD application was successful at tumor bleeding sites. Immediate hemostasis occurred in 40/41 (97.5%) patients, and re-bleeding within 28 days occurred in 10 of 40 (22.5%) patients that achieved initial hemostasis. The success rate of immediate hemostasis for UI-EWD monotherapy was 100% (23/23). The re-bleeding rate at 28 days after UI-EWD monotherapy was 26.1% (6/23). No adverse events associated with UI-EWD application were encountered. Conclusions The success rate of UI-EWD for immediate hemostasis in cases of GI tumor bleeding was excellent and UI-EWD produced promising results with respect to the prevention of re-bleeding. Based on these results, we suggest that UI-EWD be considered an effective salvage therapy or even monotherapy for GI tumor bleeding.

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Section: Discussionsupporting

confidence: 93%

“…Second, the number of study subjects was relatively small. However, previous studies on the effects of hemostatic powders on tumor bleeding enrolled fewer than 20 patients [ 24 ]. In fact, the present study was conducted on a larger cohort and with longer follow up than previous studies on the topic.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding

et al. 2021

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“…Die Substanzen haben möglicherweise einen Stellenwert bei diffusen Blutungen, wie z. B. Tumorblutungen [18,19] und sind aktuell als Reserveverfahren oder additive Option zu erachten, wenn die Standardtherapie versagt oder nicht ausreichend ist. In der Erstlinientherapie haben Hämostasesprays aktuell keinen Stellenwert.…”

Section: Hämostasespraysunclassified

Management gastrointestinaler Blutungen unter Antikoagulation

2020

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ZUSAMMENFASSUNGDie endoskopische Therapie bei gastrointestinalen Blutungen ist hoch effektiv und sicher, auch unter Einnahme von Antikoagulanzien. Das technische Vorgehen unterscheidet sich nicht vom Vorgehen bei fehlender Einnahme von Antikoagulanzien, wobei z. B. der Stellenwert einer primären OTSC („over-the-scope clip“, Ovesco Endoscopy)-Applikation bei Hochrisikopatienten noch untersucht werden muss. Das Management der Antikoagulation unterscheidet sich zwischen den unterschiedlichen Präparaten und der zugrundeliegenden Indikation und muss dem individuellen Risiko angepasst werden. Thrombozytenaggregationshemmer sollten maximal für die Intervention pausiert und früh wieder verabreicht werden. Das Management unter dualer Plättchenhemmung oder Triple-Therapie ist zwingend interdisziplinär abzusprechen. Bei Niedrigrisikosituation kann die duale Therapie in der Regel fortgeführt werden. Bei vitaler Blutung unter Vollantikoagulation ist eine Antagonisierung empfohlen, bei nicht vitaler Blutung ist diese abhängig vom endoskopischen Erfolg. Die Vollantikoagulation sollte frühestmöglich, in der Regel nach ca. 7 Tagen, wieder aufgenommen werden (Ausnahmen: mechanische Herzklappen, frisch implantierte Bioklappen, sehr hohes Thromboembolierisiko).

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“…In a pilot study by Chen et al 11 in the current issue of Gastrointestinal Endoscopy, patients with bleeding upper or lower GI malignancies were randomized to receive TC-325 or the standard-of-care hemostatic treatment during endoscopy. The primary outcome was immediate hemostasis.…”

mentioning

confidence: 99%

Is hemospray the ultimate answer to malignant GI bleeding?

Chan

Lau

2020

Gastrointestinal Endoscopy

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

Cited by 49 publications

References 27 publications

Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding

Efficacy of a novel hemostatic adhesive powder in patients with upper gastrointestinal tumor bleeding

Management gastrointestinaler Blutungen unter Antikoagulation

Is hemospray the ultimate answer to malignant GI bleeding?

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