没有先前的随机对照试验(RCT)报道了与标准止血相比,大型超镜检查夹(OTSC)作为严重NVUGIB的初始内镜治疗的患者结局。这是我们的研究目的。
有出血性溃疡或Dieulafoy病变和大出血柱头的患者-SRH(主动喷射出血,可见的血管,或凝块)-或较少的SRH(渗出出血或平坦点-通过多普勒探头显示动脉血流)被随机分配到OTSC或标准内镜止血(使用血刀或多极电凝-MPEC)。患者及其医疗保健提供者对治疗方法视而不见,并做出了所有随机化后的管理决策。溃疡患者接受大剂量静脉输注质子泵抑制剂(PPI)3天,然后口服PPI27天。前瞻性记录30天的结果;采用SAS进行数据管理;由统计学家进行数据分析。
53名患者(25名OTSC,28标准)是随机的,具有相似的基线风险因素。然而,OTSC与标准组再出血率(4%vs.28.6%;p=0.017;相对危险度0.10,95%置信区间0.01,0.91;需要治疗的数量4);严重并发症(0%vs.14.3%);红细胞输血的随机化后单位(0.04vs.0.68)。所有再出血均发生在严重SRH患者中,没有发生较少SRH患者。
1.OTSC显著降低再出血率,严重并发症,和随机化后红细胞输血。2.大柱头患者从OTSC止血中获益显著,但是污名较小的人没有。(ClinicalTrials.gov,编号:NCT03065465)。
No prior randomized controlled
trial (RCT) has reported patient outcomes of large over-the-scope clip (OTSC) compared to standard hemostasis as initial endoscopic treatment of severe NVUGIB. This was our
study aim.
Patients with bleeding ulcers or Dieulafoy\'s lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Ulcer patients received high dose intravenous infusions of proton pump inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were prospectively recorded; data management was with SAS; and data analysis was by a statistician.
53 patients (25 OTSC, 28 Standard) were randomized, with similar baseline risk factors. However, there were significant differences in OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = .017; relative risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe complications (0 % vs. 14.3%); and post-randomization units of red cell transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH and none with lesser SRH.
1. OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions. 2. Patients with major stigmata benefited significantly from hemostasis with OTSC, but those with lesser stigmata did not. (ClinicalTrials.gov, Number: NCT03065465).