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

Shin, Jongbeom; Cha, Boram; Park, Jin-Seok; Ko, Weon-Jin; Kwon, Kye Sook; Lee, Jin Woo; Kim, Hyung Kil; Shin, Yong Woon

doi:10.1186/s12876-021-01611-0

Cited by 24 publications

(19 citation statements)

References 29 publications

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“…Shin et al studied UI-EWD use as monotherapy or rescue in 41 patients with malignant bleeding, including carcinoma, gastrointestinal stromal tumor, and lymphoma. Immediate hemostasis rate was high at 97.5 % and rebleeding rate was 22.5 % in 28 days 76 .…”

Section: Resultsmentioning

confidence: 90%

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

et al. 2022

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Background and study aims Hemostatic powders are increasingly used to address limitations in conventional endoscopic techniques for gastrointestinal bleeding. Various agents exist with different compositions, characteristics, efficacy, and adverse events (AEs). We sought to review existing hemostatic powders, from preclinical to established agents. Methods A literature review on hemostatic powders for gastrointestinal bleeding was undertaken through a MEDLINE search from 2000–2021 and hand searching of articles. Relevant literature was critically appraised and reviewed for mechanism of action, hemostasis and rebleeding rate, factors associated with hemostatic failure, and AEs. Results The most established agents are TC-325 (Hemospray), EndoClot, and Ankaferd Blood Stopper (ABS). These agents have been successfully applied to a variety of upper and lower gastrointestinal bleeding etiologies, in the form of primary, combination, salvage, and bridging therapy. Few AEs have been reported, including visceral perforation, venous embolism, and self-limited abdominal pain. Newer agents include CEGP-003 and UI-EWD, which have shown results similar to those for the older agents in initial clinical studies. All aforementioned powders have high immediate hemostasis rates, particularly in scenarios not amenable to conventional endoscopic methods, but are limited by significant rates of rebleeding. Other treatments include TDM-621 (PuraStat) consisting of a liquid hemostatic agent newly applied to endoscopy and self-propelling thrombin powder (CounterFlow Powder), a preclinical but promising agent. Conclusions Rapid development of hemostatic powders and growing clinical expertise has established these agents as a valuable strategy in gastrointestinal bleeding. Further research will continue to refine the efficacy and applicability of these agents.

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Section: Resultsmentioning

confidence: 90%

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

et al. 2022

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“…A cohort of 41 patients with GI tumor bleeding treated with TC-325 achieved immediate hemostasis in 97.5% and 28 days rebleeding in 22.5%. [11] A retrospective study including 12 patients with gastric malignant bleeding treated with a similar hemostatic powder reported immediate hemostasis in all patients and rebleeding in 16% [12]. A systematic review and meta-analysis including 11 prospective studies and 4 randomized trials found an immediate hemostasis rate of 93% with TC-325 powder (95% CI 90.3-95%, p < 0.001) [10].…”

Section: Discussionmentioning

confidence: 99%

“…Chen et al conducted a randomized pilot trial comparing TC-325 with a standard of care (SOC) group, achieving immediate hemostasis in 90 % of patients treated with TC-325 versus 40 % in the SOC group ( P = 0.057) 4 . A cohort of 41 patients with gastrointestinal tumor bleeding treated with TC-325 achieved immediate hemostasis in 97.5 % and 28 days rebleeding in 22.5 % 11 . A retrospective study including 12 patients with gastric malignant bleeding treated with a similar hemostatic powder reported immediate hemostasis in all patients and rebleeding in 16 % 12 .…”

Section: Discussionmentioning

confidence: 99%

TC-325 hemostatic powder in the management of upper gastrointestinal malignant bleeding: a randomized controlled trial

et al. 2022

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BACKGROUND: Upper gastrointestinal bleeding (UGIB) from malignancy is associated with high rebleeding and mortality rates. Recently, TC-325 powder has shown promising results in the treatment of UGIB, including malignant bleeding. The aim of this study was to compare the efficacy of TC-325 versus best clinical management. METHODS: From August 2016 to February 2020, all patients with evidence of UGIB from malignancy were randomized to receive TC-325 therapy or control group, in which endoscopic treatment was not mandatory. Exclusion criteria were hemoglobin drop without overt bleeding and UGIB from non-tumor origin. The primary outcome was 30-day mortality. Secondary outcomes were 30-day rebleeding, blood transfusion and length of hospital stay. RESULTS: 62 patients were randomized, 3 were excluded and 59 were included in the final analysis (TC-325 group=28; control=31). Groups were similar at baseline. Active bleeding was observed in 22 patients in the TC-325 group and 19 in the control group (p = 0.15). Successful initial hemostasis with TC-325 was achieved in all cases. Additional therapy (radiotherapy, surgery or arterial embolization) was equally performed in both groups (42.9% vs 58.1%; p= 0.243). There were no differences in 30-day mortality (28.6% vs. 19.4%, p= 0.406) or 30-day rebleeding rates (32.1% vs. 19.4%, p= 0.26). Logistic regression identified no significant predictors of rebleeding. Age, Eastern Cooperative Oncology Group (ECOG) score 3-4 and AIMS65 score > 1 predicted greater mortality. CONCLUSION: TC-325 was effective in achieving immediate hemostasis in malignant GI bleeding but did not reduce 30-day mortality, 30-day rebleeding, blood transfusion or length of hospital stay. Age, ECOG 3-4, and AIMS65 >1 were predictive factors of mortality.

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“…Chen et al [ 20 ] reported its use in five patients with tumoral GI bleeding and found that all experienced immediate bleeding control, and only one case had rebleeding. Shin et al [ 21 ] also reported immediate bleeding control in all patients with the use of the hemostatic powder in a study with 41 consecutive patients with tumoral UGIB. Although a hemostatic powder seems to be a safe and reliable option for hemostasis of tumoral bleeding, it was not available yet in our institution during the period of this study.…”

Section: Discussionmentioning

confidence: 99%

Risk Stratification in Cancer Patients with Acute Upper Gastrointestinal Bleeding: Comparison of Glasgow-Blatchford, Rockall and AIMS65, and Development of a New Scoring System

et al. 2022

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In a recent series of patients with cancer at the Cancer Institute of Sao Paulo, we found that tumor bleeding was the main cause of upper gastrointestinal bleeding (UGIB; 23.8%), followed by varices (19.7%) and ulcers (16.3%). 1 The rates of mortality from UGIB in the general population ranges from 3.5% to 20%, 2,3 and it is even higher in cancer patients presenting with overt UGIB, approaching 45%. 1 It is recommended that patients with UGIB should be stratified into low or high risk of needing early hospital-based intervention and death. 4,5 For that purpose, prognostic scores, which take into consideration clinical and endoscopic findings, are employed.The Rockall score (RS) was primarily designed to assess the 30-day mortality after an episode of UGIB. 6 Patients with a total RS ≤ 2 are considered at low risk. 7 Similarly, the Glasgow-Blatchford score (GBS) was developed to predict the 30-day mortality and need for intervention. The advantage of GBS is that endoscopic findings are not a part of the scoring criteria, allowing for a more rapid risk assessment. Patients with GBS ≥1 are considered high-risk. 8 A relatively new

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

Cited by 24 publications

References 29 publications

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field

TC-325 hemostatic powder in the management of upper gastrointestinal malignant bleeding: a randomized controlled trial

Risk Stratification in Cancer Patients with Acute Upper Gastrointestinal Bleeding: Comparison of Glasgow-Blatchford, Rockall and AIMS65, and Development of a New Scoring System

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