Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong SAR, China (J.Y.W.L., K.Y.Y.Y., B.Y.S., F.K.L.C.).
The First Affiliated Hospital of Soochow University, Suzhou, China (R.L., C.T., D.S.).
Ann Intern Med. 2023 Apr;176(4):455-462. doi: 10.7326/M22-1783. Epub 2023 Mar 7.
Current endoscopic methods in the control of acute nonvariceal bleeding have a small but clinically significant failure rate. The role of over-the-scope clips (OTSCs) as the first treatment has not been defined.
To compare OTSCs with standard endoscopic hemostatic treatments in the control of bleeding from nonvariceal upper gastrointestinal causes.
A multicenter, randomized controlled trial. (ClinicalTrials.gov: NCT03216395).
University teaching hospitals in Hong Kong, China, and Australia.
190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy.
Standard hemostatic treatment ( = 97) or OTSC ( = 93).
The primary outcome was 30-day probability of further bleeds. Other outcomes included failure to control bleeding after assigned endoscopic treatment, recurrent bleeding after initial hemostasis, further intervention, blood transfusion, and hospitalization.
The 30-day probability of further bleeding in the standard treatment and OTSC groups was 14.6% (14 of 97) and 3.2% (3 of 93), respectively (risk difference, 11.4 percentage points [95% CI, 3.3 to 20.0 percentage points]; = 0.006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 (risk difference, 5.1 percentage points [CI, 0.7 to 11.8 percentage points]), respectively, and 30-day recurrent bleeding was 8 versus 2 (risk difference, 6.6 percentage points [CI, -0.3 to 14.4 percentage points]), respectively. The need for further interventions was 8 versus 2, respectively. Thirty-day mortality was 4 versus 2, respectively. In a post hoc analysis with a composite end point of failure to successfully apply assigned treatment and further bleeds, the event rate was 15 of 97 (15.6%) and 6 of 93 (6.5%) in the standard and OTSC groups, respectively (risk difference, 9.1 percentage points [CI, 0.004 to 18.3 percentage points]).
Clinicians were not blinded to treatment and the option of crossover treatment.
Over-the-scope clips, as an initial treatment, may be better than standard treatment in reducing the risk for further bleeding from nonvariceal upper gastrointestinal causes that are amenable to OTSC placement.
General Research Fund to the University Grant Committee, Hong Kong SAR Government.
目前控制急性非静脉曲张性出血的内镜方法的失败率虽小，但具有临床意义。作为首选治疗方法的内镜下夹闭术（OTSC）的作用尚未明确。
比较 OTSC 与标准内镜止血治疗在控制非静脉曲张性上消化道出血中的作用。
多中心、随机对照试验。（ClinicalTrials.gov：NCT03216395）。
中国香港和澳大利亚的大学教学医院。
190 例接受上消化道内镜检查时发现有非静脉曲张性上消化道出血或无出血可见血管的成人患者。
标准止血治疗（=97）或 OTSC（=93）。
主要结局是 30 天内再次出血的概率。其他结局包括内镜治疗后仍有出血、初始止血后再次出血、进一步治疗、输血和住院。
标准治疗组和 OTSC 组 30 天内再次出血的概率分别为 14.6%（97 例中的 14 例）和 3.2%（93 例中的 3 例）（风险差异，11.4 个百分点[95%CI，3.3 至 20.0 个百分点]；=0.006）。标准治疗组和 OTSC 组内镜治疗后仍有出血的比例分别为 6 例和 1 例（风险差异，5.1 个百分点[CI，0.7 至 11.8 个百分点]），30 天内再次出血的比例分别为 8 例和 2 例（风险差异，6.6 个百分点[CI，-0.3 至 14.4 个百分点]），进一步干预的比例分别为 8 例和 2 例。30 天死亡率分别为 4 例和 2 例。在一项包含未能成功应用指定治疗和进一步出血的复合终点的事后分析中，标准治疗组和 OTSC 组的事件发生率分别为 15 例（15.6%）和 6 例（6.5%）（风险差异，9.1 个百分点[CI，0.004 至 18.3 个百分点]）。
临床医生未对治疗进行盲法，也未对交叉治疗进行盲法。
作为初始治疗方法，OTSC 可能优于标准治疗，可降低可应用 OTSC 治疗的非静脉曲张性上消化道出血再次出血的风险。
香港特别行政区政府大学教育资助委员会的一般研究基金。
