Long-Term Effectiveness, Safety and Mortality Associated with the Use of TC-325 for Malignancy-Related Upper Gastrointestinal Bleeds: A Multicentre Retrospective Study

BACKGROUND AND STUDY AIMS: Malignant-related upper gastrointestinal bleeding (MRUGIB) is difficult to treat by conventional endoscopic methods. We sought to determine the efficacy, safety and mortality associated with the use of TC-325 for the treatment of MUGIB. PATIENTS AND METHODS: This is a multicentre, retrospective study at the University of Calgary and University of Ottawa performed between January 1, 2010, and July 30, 2016. TC-325 use was identified via staff polling, product order forms and endoscopic records review. Once identified, patient charts and online records were examined to identify MRUGIB cases and to assess our primary and secondary endpoints. OUTCOMES: The primary outcome was hemostasis at seven days. Secondary outcomes include immediate hemostasis, early hemostasis, hemostasis at 14 days, 30-day mortality, adverse events related to TC-325 therapy and the need for repeat endoscopic intervention, surgery or transarterial embolization. RESULTS: Twenty-five patients were identified. The median age was 62 years (interquartile range [IQR] 52.5–76), and most were male (64%). TC-325 was the primary treatment modality in 20 patients (80%). Hemostasis was 88%, 89%, 58% and 50% at 24 hours, 72 hours, 7 days and 14 days, respectively. Five patients underwent repeat endoscopy, two patients required surgical intervention, and transarterial embolization was not required. Twelve patients died by 30 days (48%). There were no complications directly attributed to the use of TC-325. CONCLUSIONS: TC-325 is effective for achieving and maintaining hemostasis in patients with malignancy-related upper gastrointestinal bleeding, and most patients do not require additional interventions. The 30-day mortality risk in this group of patients is high.