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

ABSTRACT: Background and study aims 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. Patients and 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 Sixty-two patients were randomized, three 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 to 4 and AIMS65 score > 1 predicted greater mortality. Conclusions TC-325 was effective in achieving immediate hemostasis in malignant gastrointestinal 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.

SUBMITTER: Martins BC

PROVIDER: S-EPMC9576337 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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

Martins Bruno Costa BC Abnader Machado Andressa A Scomparin Rodrigo Corsato RC Paulo Gustavo Andrade GA Safatle-Ribeiro Adriana A Naschold Geiger Sebastian S Lenz Luciano L Lima Marcelo Simas MS Pennacchi Caterina C Ribeiro Ulysses U Barkun Alan N AN Maluf-Filho Fauze F

Endoscopy international open 20221017 10

<b>Background and study aims </b> 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. <b>Patients and methods </b> From August 2016 to February 2020, all patients with evidence of UGIB from malignancy were randomized to receive TC-325 thera ...[more]

PMID: 36262517

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Project description:Background and study aims Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Methods Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I 2 %. Results Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I 2 43), P = 0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I 2 35), P = 0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I 2 0), P = 0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I 2 0), P = 0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I 2 26), P = 0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I 2 62), P = 0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I 2 0), P = 0.02. Conclusions Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.

Project description:Background and study aims Novel topical hemostatic agents have shown promising results in treating patients with non-variceal upper gastrointestinal bleeding (NVUGIB). However, data are limited even in published meta-analyses as to their role, especially compared to conventional endoscopic approaches. The aim of this study was to perform a highly comprehensive systematic review assessing the effectiveness of topical hemostatic agents in UGIB in different clinical settings. Methods We performed a literature search of OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases through September 2021. Studies assessing the efficacy of topical hemostatic agents in UGIB were included. Main outcomes were immediate hemostasis and overall rebleeding. Results A total of 980 citations were identified and 59 studies with a total of 3,417 patients were included in the analysis. Immediate hemostasis was achieved in 93 % (91 %; 94 %), with similar results according to etiology (NVUGIB vs. variceal), topical agent used, or treatment strategy (primary vs. rescue). The overall rebleeding rate was 18 % (15%; 21 %) with the majority of rebleeds occurring in the first 7 days. Among comparative studies, topical agents achieved immediate hemostasis more often than standard endoscopic modalities (OR 3.94 [1.73; 8.96), with non-different overall rebleeding odds (OR 1.06 [0.65; 1.74]). Adverse events occurred in 2 % (1 %; 3 %). Study quality was overall low to very low. Conclusions Topical hemostatic agents are effective and safe in the management of UGIB with favorable outcomes when compared to conventional endoscopic modalities across a variety of bleeding etiologies. This is especially true in novel subgroup analyses that assessed immediate hemostasis and rebleeding among RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to ascertain their effectiveness more confidently in the management of patients with UGIB.

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

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

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