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

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.

Clinical and endoscopic aspects of metastases to the gastrointestinal tract.

BACKGROUND: Studies that describe metastases to the gastrointestinal (GI) tract are restricted to small case series. An increase in the frequency of this condition is expected, so it would be useful to better characterize the endoscopic aspects of metastasis to the GI tract. The aims of this study were to describe the frequency and endoscopic features of the lesions, and to analyze the survival rate after diagnosis of metastasis. METHODS: This was a retrospective, single-center, observational study, conducted between 2009 and 2017. Patients with metastasis to the GI tract were included. RESULTS: 95 patients were included. Melanoma (25.3 %), lung (15.8 %), and breast (14.7 %) were the most frequent primary tumors. The most common endoscopic presentation was a solitary, ulcerated lesion in the gastric body. Conventional biopsy was diagnostic in 98.9 % of the cases. The mean and median survival rates were 13.3 months (95 % confidence interval [CI] 8.2 - 18.3) and 4.7 months (95 %CI 3.7 - 5.6), respectively. Palliative treatment with chemo- and/or radiotherapy after the diagnosis of the metastasis was related to a higher survival rate. CONCLUSIONS: Melanoma, lung, and breast cancer were the most common primary tumors to metastasize to the GI tract. The endoscopic features could not predict the primary site of the tumor. The finding of metastasis in the GI tract is related to the final stage of the cancer disease but patients who received palliative treatment with chemo- and/or radiotherapy after diagnosis of GI metastasis had higher survival rates.