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Background and aims <p>Endoscopic variceal ligation (EVL) is associated with relatively high rebleeding rates in patients with large esophageal varices (EVs). However, objective and clinically applicable methods for measuring esophageal variceal diameter (EVD) remain limited. This study aimed to introduce a novel non-invasive EVD measurement technique and to compare the efficacy of balloon-occluded esophageal varices obliteration (BEVO) with EVL in patients with high-risk EVs (HREVs), focusing on rebleeding and survival outcomes across different EVD subgroups.</p> Methods <p>EVD was measured endoscopically using an artificial intelligence-assisted virtual ruler. In this prospective randomized controlled trial, patients with HREVs of varying diameters treated between December 2020 and January 2024 were randomly assigned to receive BEVO (<i>n</i> = 107) or EVL (<i>n</i> = 107). Primary and secondary outcomes included rebleeding rates, number of treatment sessions, adverse events, and overall survival.</p> Results <p>Compared with EVL, BEVO was associated with significantly lower total rebleeding rates (13.08% vs. 27.10%, <i>P</i> = 0.010) and late rebleeding rates (11.21% vs. 23.36%, <i>P</i> = 0.019). Among patients with EVD ≥ 10&#xa0;mm, EVL was associated with significantly higher rebleeding rates (9.09% vs. 25.35%, <i>P</i> = 0.03), with this difference becoming more pronounced in those with EVD ≥ 15&#xa0;mm (17.65% vs. 100.00%, <i>P</i> &lt; 0.0001). Multivariate Cox regression analysis identified EVL, compared to BEVO, as an independent predictor of rebleeding (HR 2.21, 95% CI 1.17–4.18, <i>P</i> = 0.015). Patients treated with EVL required more treatment sessions than those treated with BEVO (<i>P</i> = 0.028). Furthermore, patients without rebleeding demonstrated significantly higher survival rates than those with rebleeding (94.15% vs. 69.76%, <i>P</i> &lt; 0.001).</p> Conclusion <p>In this study population, BEVO demonstrated superior efficacy to EVL in preventing rebleeding in HREVs, particularly those with EVD ≥ 10&#xa0;mm. These findings suggest BEVO as a promising therapeutic strategy, warranting further validation in multicenter studies.</p> Clinical trial number <p>ChiCTR2000039974.</p>

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Comparison of balloon-occluded esophageal varices obliteration and endoscopic variceal ligation for high-risk esophageal varices of various diameters: a prospective randomized controlled trial

  • 期刊论文

  • 发表日期：

    2026年2月2日

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  • Zhihong Wang,
  • Yuchuan Bai,
  • Yaxian Kuai,
  • Zhuang Zeng,
  • Qianqian Zhang,
  • Xuecan Mei,
  • Derun Kong

摘要

Background and aims

Endoscopic variceal ligation (EVL) is associated with relatively high rebleeding rates in patients with large esophageal varices (EVs). However, objective and clinically applicable methods for measuring esophageal variceal diameter (EVD) remain limited. This study aimed to introduce a novel non-invasive EVD measurement technique and to compare the efficacy of balloon-occluded esophageal varices obliteration (BEVO) with EVL in patients with high-risk EVs (HREVs), focusing on rebleeding and survival outcomes across different EVD subgroups.

Methods

EVD was measured endoscopically using an artificial intelligence-assisted virtual ruler. In this prospective randomized controlled trial, patients with HREVs of varying diameters treated between December 2020 and January 2024 were randomly assigned to receive BEVO (n = 107) or EVL (n = 107). Primary and secondary outcomes included rebleeding rates, number of treatment sessions, adverse events, and overall survival.

Results

Compared with EVL, BEVO was associated with significantly lower total rebleeding rates (13.08% vs. 27.10%, P = 0.010) and late rebleeding rates (11.21% vs. 23.36%, P = 0.019). Among patients with EVD ≥ 10 mm, EVL was associated with significantly higher rebleeding rates (9.09% vs. 25.35%, P = 0.03), with this difference becoming more pronounced in those with EVD ≥ 15 mm (17.65% vs. 100.00%, P < 0.0001). Multivariate Cox regression analysis identified EVL, compared to BEVO, as an independent predictor of rebleeding (HR 2.21, 95% CI 1.17–4.18, P = 0.015). Patients treated with EVL required more treatment sessions than those treated with BEVO (P = 0.028). Furthermore, patients without rebleeding demonstrated significantly higher survival rates than those with rebleeding (94.15% vs. 69.76%, P < 0.001).

Conclusion

In this study population, BEVO demonstrated superior efficacy to EVL in preventing rebleeding in HREVs, particularly those with EVD ≥ 10 mm. These findings suggest BEVO as a promising therapeutic strategy, warranting further validation in multicenter studies.

Clinical trial number

ChiCTR2000039974.