Department of Gastroenterology and Gastrointestinal Oncology, University Medical Centre Goettingen, Georg-August-University, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, 79106, Freiburg, Germany.
Surg Endosc. 2018 Jan;32(1):307-314. doi: 10.1007/s00464-017-5678-7. Epub 2017 Jun 27.
The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB.
In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4-7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test.
Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001).
This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.
套扎器（OTSC）克服了标准夹的局限性，在非静脉曲张性上消化道出血（NVUGIB）中实现了更有效和可靠的止血。本研究旨在评估在 NVUGIB 中，将 OTSC 用作一线内镜治疗（FLET）的患者的死亡率、再出血率和再出血后死亡率。
共纳入 118 名中位年龄为 73.5 岁（范围 29-93 岁；平均（±SD）71.39 ± 12.39 岁）的患者（FLET 队列）。根据风险类别分布，患者的 Rockall 评分中位数为 7 分（范围 3-10 分）。为了进行假设检验，考虑到 Rockall 评分，FLET 队列被分为三个风险组：低危组[Rockall 风险类别（RRC≤3]、中危组（RRC 4-7）和高危组（RRC≥8）。使用 Fisher 精确检验比较每个风险组的观察到的事件发生率（死亡率、再出血率和再出血后死亡率）与预测的事件发生率（Rockall 队列）。
92.4%的患者通过 FLET 单独或联合使用其他止血技术实现了主要即刻止血（PSH），1.7%的患者（SCS=次要临床成功）需要进一步治疗。在 FLET 队列中，7.5%的患者无法实现 PSH。与 RRC 预测相比，高危组（RRC≥8）接受 FLET 治疗后，再出血后死亡率从 27.9%显著降低至 10.9%（p<0.011）。此外，中危组（RRC 4-7）的再出血或持续出血发生率为 4.9%，高危组（RRC≥8）为 21.4%，明显低于 Rockall 队列的 24.0%和 53.2%（p<0.001）。
本研究表明，OTSC 优于标准治疗，FLET 可显著降低 NVUGIB 中的再出血和再出血相关死亡率。因此，OTSC 可以作为高危患者的一线治疗选择，替代标准止血技术。
