Institute of Digestive Disease, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong, China.
Department of Gastroenterology, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Gut. 2019 May;68(5):796-803. doi: 10.1136/gutjnl-2018-316074. Epub 2018 May 25.
In the management of patients with bleeding peptic ulcers, recurrent bleeding is associated with high mortality. We investigated if added angiographic embolisation after endoscopic haemostasis to high-risk ulcers could reduce recurrent bleeding.
After endoscopic haemostasis to their bleeding gastroduodenal ulcers, we randomised patients with at least one of these criteria (ulcers≥20 mm in size, spurting bleeding, hypotensive shock or haemoglobin<9 g/dL) to receive added angiographic embolisation or standard treatment. Our primary endpoint was recurrent bleeding within 30 days.
Between January 2010 and July 2014, 241 patients were randomised (added angiographic embolisation n=118, standard treatment n=123); 22 of 118 patients (18.6%) randomised to angiography did not receive embolisation. In an intention-to-treat analysis, 12 (10.2%) in the embolisation and 14 (11.4%) in the standard treatment group reached the primary endpoint (HR 1.14, 95% CI 0.53 to 2.46; p=0.745). The rate of reinterventions (13 vs 17; p=0.510) and deaths (3 vs 5, p=0.519) were similar. In a per-protocol analysis, 6 of 96 (6.2%) rebled after embolisation compared with 14 of 123 (11.4%) in the standard treatment group (HR 1.89, 95% CI 0.73 to 4.92; p=0.192). None of 96 patients died after embolisation compared with 5 (4.1%) deaths in the standard treatment group (p=0.108). In a posthoc analysis, embolisation reduced recurrent bleeding only in patients with ulcers≥15 mm in size (2 (4.5%) vs 12 (23.1%); p=0.027).
After endoscopic haemostasis, added embolisation does not reduce recurrent bleeding.
NCT01142180.
在治疗出血性消化性溃疡患者时，再次出血与高死亡率相关。我们研究了内镜止血后对高危溃疡进行血管造影栓塞是否能减少再次出血。
对胃十二指肠出血性溃疡患者进行内镜止血后，我们将至少符合以下一项标准的患者（溃疡＞20mm 大小、喷血、低血压休克或血红蛋白＜9g/dL）随机分为接受附加血管造影栓塞或标准治疗的组。我们的主要终点是 30 天内再次出血。
2010 年 1 月至 2014 年 7 月，共随机分配了 241 名患者（附加血管造影栓塞 n=118，标准治疗 n=123）；随机分至血管造影组的 22 名患者（18.6%）未接受栓塞。意向治疗分析中，栓塞组有 12 名（10.2%）和标准治疗组有 14 名（11.4%）患者达到了主要终点（HR 1.14，95%CI 0.53 至 2.46；p=0.745）。再干预率（13 比 17；p=0.510）和死亡率（3 比 5，p=0.519）相似。在符合方案分析中，栓塞组有 6 名（6.2%）患者再次出血，而标准治疗组有 14 名（11.4%）患者再次出血（HR 1.89，95%CI 0.73 至 4.92；p=0.192）。栓塞组 96 名患者中无死亡，而标准治疗组有 5 名（4.1%）患者死亡（p=0.108）。事后分析显示，栓塞仅能减少溃疡≥15mm 的患者再次出血（2 比 12；p=0.027）。
内镜止血后，附加栓塞并不能减少再次出血。
NCT01142180。
