Background Gastrointestinal bleeding is a common disease among the population in Taiwan, with gastrointestinal tumor bleeding accounting for 3-5% of cases. The pathophysiology of gastrointestinal tumor bleeding is unique, involving fragile surface mucosa, abnormal vascular proliferation, and malformation, making endoscopic hemostasis challenging. Conventional endoscopic hemostasis methods such as hemostatic injections, clips, or thermal coagulation have suboptimal success rates below 80%, with recurrence rates exceeding 50%. Recent clinical trials have demonstrated that hemostatic powder spraying effectively enhances hemostasis for gastrointestinal ulcers and reduces recurrence rates. Our previous research repurposed tranexamic acid in a powder form to enhance hemostasis for peptic ulcer and applied sucralfate powder to prevent postpolypectomy wound bleeding.
Study aim Our research team combines previous experience by using tranexamic acid and sucralfate drug powders to spray onto bleeding gastrointestinal tumors to achieve hemostatic effects. Additionally, tumor-derived exosomes are associated with tumor angiogenesis and growth, so we hypothesize that gastrointestinal tumor bleeding may be linked to VEGF and miR-21 expression within gastrointestinal tumor exosomes.
Study method This study is a clinical randomized controlled trial conducted at National Cheng Kung University Hospital. We will recruit 60 patients with gastrointestinal tumor bleeding undergoing endoscopic hemostasis. Patients in the experimental treatment group will receive additional topical administration of 1.5 g of tranexamic acid and 3 g of sucralfate drug powder. Immediate hemostasis and 30-day bleeding recurrence will be observed. Enrolled patients will also provide blood and tumor specimens for exosome analysis, evaluating the predictive effect of extracted tumor exosomes' VEGF and miR-21 on bleeding risk. This study will explore the association between specific tumor exosome expression levels and bleeding, serving as a basis for bleeding risk assessment and innovative therapies.
patients aged ≥ 18 years who accept endoscopy for upper GI tumor bleeding
patients with no need for endoscopic hemostasis, allergy to sucralfate, tranexamic acid, pregnancy, and patients with hollow organ perforation
Crossover
3g of sucralfate powder and 1.5g of tranexamic acid powder
DrugFor patients in the intervention group, we will additionally deliver 3g of sucralfate powder and 1.5g of tranexamic acid powder through the endoscopy precisely on the bleeding site after conventional therapy. After endoscopic treatment, 5 minutes of observation time is needed for the immediate hemostasis confirmation. After endoscopic hemostasis, patients with upper gastrointestinal lesions received an intravenous 80-mg bolus of proton pump inhibitors followed by 8 mg/h continuously for at least 72 hours.
Standard Treatment
DrugEpinephrine injection, clipping, and heat coagulation will be applied. The decision for the choice of standard therapy was left to the discretion of the endoscopist in the absence of any recommendations or proof of superiority of one modality over another in the initial endoscopic approach to use in patients presenting with malignant bleeding.
30-day rebleeding
Rebleeding was defined by any of the following criteria: (1) hematemesis or bloody nasogastric tube drainage occurring more than 6 hours after endoscopy; (2) melena recurring after initial normalization of stool color; (3) hematochezia occurring after normalization of stool color or melena; (4) development of tachycardia (heart rate ≥110 beats/min) or hypotension (systolic blood pressure ≤90 mm Hg) after at least 1 hour of stable vital signs without other identifiable cause; (5) a hemoglobin drop of ≥2 g/dL following two consecutive stable hemoglobin measurements; (6) tachycardia or hypotension persisting beyond 8 hours after the index endoscopy despite appropriate resuscitation, without alternative explanation, accompanied by ongoing melena or hematochezia; or (7) a persistent hemoglobin decline of \>3 g/dL within 24 hours together with ongoing melena or hematochezia.
immediate hemostasis
no evidence of further bleeding after 3 minutes of observation during the index endoscopy, with elapsed time measured by a stopwatch.
rebleeding in need of TAE or surgery
rebleeding in need of TAE or surgery
all cause mortality
all cause mortality
hospitalization day
hospitalization day
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