A randomized controlled trial comparing large-volume band ligator and cyanoacrylate injection in the endoscopic management of actively bleeding gastric varices.

Managing actively bleeding gastric varices (GV) is clinically challenging. This study assessed the safety and efficacy of endoscopic band ligation (EBL) using large-volume ligators compared with endoscopic variceal obturation (EVO) in managing actively bleeding GV. Patients who were diagnosed with active GV bleeding via endoscopy and underwent EBL with large-volume band ligators or EVO were enrolled. Follow-up endoscopy was performed at 1, 3, and 6 months after endoscopic treatment. Primary outcomes were the initial haemostasis success rate, GV eradication rate within 3 months, 1-week rebleeding rate, 6-month cumulative rebleeding rate, and recurrence rate within 6 months. Secondary outcomes were the rate and average volume of blood transfusions in patients with rebleeding and adverse events related to endoscopic treatment. Overall, 154 patients were included (EBL group: n = 77; EVO group: n = 77). There were no statistically significant differences between the two groups regarding the initial haemostasis success rate, 1-week rebleeding rate, 3-month GV eradication rate and average number of sessions to GV eradication, cumulative rebleeding rate, and recurrence rate within 6 months. Three of the nine patients with rebleeding in the EVO group required blood transfusion with an average blood transfusion volume that was significantly lower than that required by the five patients with rebleeding in the EBL group (P = 0.024). The fever rate was lower in the EBL group than in the EVO group (P = 0.011). In the EVO group, one patient developed a pulmonary embolism and died during treatment, and three patients developed postoperative sepsis. The short-term efficacy of EBL with large-volume ligators in the treatment of actively bleeding GV is similar to that of EVO; however, postoperative rebleeding is often more dangerous in EBL than in EVO. Therefore, EBL represents a viable alternative in emergency endoscopic control of GV bleeding, provided that a contingency plan for early band slippage-related rebleeding is implemented.Trial registration: Chinese Clinical Trial Registry (No. ChiCTR1900027588, 19/11/2019).