Xu Xiaofen, Zhang Yaopeng, Zheng Wei, Wang Yingchun, Yao Wei, Li Ke, Yan Xiue, Chang Hong, Huang Yonghui
The Department of Gastroenterology, Peking University Third Hospital, Haidian District, 49 Huayuan North Road, Beijing, China.
Surg Endosc. 2022 Nov;36(11):8202-8213. doi: 10.1007/s00464-022-09265-z. Epub 2022 May 10.
The main limitation of plastic stents is the relatively short stent patency due to occlusion. We designed enteral extended biliary stents with lengths of 26 cm (EEBS-26 cm) and 30 cm (EEBS-30 cm) to prolong stent patency. This study aimed to compare patency among EEBS-26 cm, EEBS-30 cm, and conventional plastic biliary stent (CPBS).
A single-center prospective randomized controlled study was conducted. Eligible patients were randomized into the EEBS-26 cm, EEBS-30 cm, and CPBS groups, respectively. All patients were followed up every 3 months until stent occlusion, patient death, or at 12-month follow-up. The primary outcome was stent patency. The secondary outcomes included stent occlusion rate, patient survival, mortality, the rate of technical success, and adverse events.
Totally 117 patients were randomized into the three groups. There were no significant differences among the three groups in technical success rate, hospital stay, mortality, patient survival, and adverse events (P = 1.000, 0.553, 0.965, 0.302, and 0.427, respectively). Median stent patency durations in the EEBS-26 cm, EEBS-30 cm, and CPBS groups were 156.0 (95% CI 81.6-230.4) days, 81.0 (95% CI 67.9-94.1) days, and 68.0 (95% CI 20.0-116.0) days, respectively (P = 0.002). The EEBS-26 cm group had longer stent patency compared with the CPBS (P = 0.007) and EEBS-30 cm (P < 0.001) groups. The EEBS-26 cm group had lower stent occlusion rates compared with the other groups at 6 months (48.1% vs. 90.5% vs. 82.8%, P = 0.001) and 9 months (75.0% vs. 100.0% vs. 92.9%, P = 0.022).
EEBS-26 cm has prolonged stent patency and is safe and effective for the alleviation of unresectable extrahepatic malignant biliary obstruction.
塑料支架的主要局限性在于由于堵塞导致支架通畅时间相对较短。我们设计了长度为26厘米（EEBS - 26厘米）和30厘米（EEBS - 30厘米）的肠内延长型胆管支架，以延长支架通畅时间。本研究旨在比较EEBS - 26厘米、EEBS - 30厘米和传统塑料胆管支架（CPBS）的通畅情况。
进行了一项单中心前瞻性随机对照研究。符合条件的患者分别随机分为EEBS - 26厘米组、EEBS - 30厘米组和CPBS组。所有患者每3个月随访一次，直至支架堵塞、患者死亡或随访12个月。主要结局是支架通畅情况。次要结局包括支架堵塞率、患者生存率、死亡率、技术成功率和不良事件。
总共117例患者被随机分为三组。三组在技术成功率、住院时间、死亡率、患者生存率和不良事件方面无显著差异（P分别为1.000、0.553、0.965、0.302和0.427）。EEBS - 26厘米组、EEBS - 30厘米组和CPBS组的支架通畅时间中位数分别为156.0（95%CI 81.6 - 230.4）天、81.0（95%CI 67.9 - 94.1）天和68.0（95%CI 20.0 - 116.0）天（P = 0.002）。与CPBS组（P = 0.007）和EEBS - 30厘米组（P < 0.001）相比，EEBS - 26厘米组的支架通畅时间更长。在6个月时（48.1%对90.5%对82.8%，P = 0.001）和9个月时（75.0%对100.0%对92.9%，P = 0.022），EEBS - 26厘米组的支架堵塞率低于其他组。
EEBS - 26厘米可延长支架通畅时间，对于缓解不可切除的肝外恶性胆管梗阻是安全有效的。
