1. In this randomized controlled trial, over-the-scope clips (OTSCs) reduced the risk of rebleeding in patients with a nonvariceal upper gastrointestinal (GI) cause compared to standard endoscopic treatment.
2. OTSCs did not differ from the control group in failure to control bleeding after endoscopic treatment in patients with bleeding from a nonvariceal upper GI cause.
Evidence Rating Level: 2 (Good)
Study Rundown: OTSCs are clips that are cap-mounted onto the end of an endoscope. Notably, OTSCs have been shown to be superior to standard treatment in controlling bleeding for refractory bleeding ulcers. Other randomized controlled trials have also demonstrated the superiority of OTSCs in hemostasis. However, there is a gap in knowledge as to understanding the efficacy of OTSCs as the initial treatment in the prevention of further bleeding from nonvariceal causes. Overall, this study found that OTSCs may be better than standard endoscopic treatment as the first endoscopic hemostatic therapy for high-risk nonvariceal lesions. This study was limited by not finding significant differences in secondary outcomes, not blinding the clinicians to the assigned treatment, and for limited generalizability of the trial findings. Nevertheless, these study’s findings are significant, as they demonstrate that OTSCs may be superior to standard treatment for reducing the risk of bleeding from nonvariceal upper GI causes that are amenable to OTSC placement.
Click to read the study in AIM
Relevant Reading: What Is the Current Role of an Over-the-Scope Clip Used as First-Line Endoscopic Hemostasis in Patients With Nonvariceal Upper Gastrointestinal Bleeding?
In-Depth [randomized controlled trial]: This randomized controlled trial was conducted at university teaching hospitals in Hong Kong, China, and Australia. Patients with acute upper GI bleeding (melena, hematemesis, or decreased hemoglobin level) were eligible for the study (n=190). Patients with esophagogastric varices, pregnant or lactating women, patients who could not provide written consent, and moribund patients not considered for active treatment. Patients with lesions with endoscopic appearance or positions considered not favorable for OTSC placement were also excluded from the study. The primary outcome measured was the probability of further bleeding defined by the composite of failure to control bleeding after assigned endoscopic treatment and recurrent bleeding within 30 days. Outcomes in the primary analysis were assessed via the intention to treat principle with risk differences and Kaplan-Meier curves. Based on the primary analysis, 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%; 95% Confidence Interval [CI], 3.3 to 20.0%; p=0.006). There was no significant difference in the failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups (risk difference, 5.1%; 95% CI, 0.7 to 11.8%), respectively, and no significant difference in 30-day recurrent bleeding (risk difference, 6.6%; 95% CI, -0.3 to 14.4%). Overall, this study demonstrated that OTSCs may be superior to standard treatment in reducing the risk of further bleeding from nonvariceal upper GI bleeding in patients with causes amenable to OTSC placement.
Image: PD
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