1. Comparison of Over-the-Scope Clips to Standard Endoscopic Treatment as the Initial Treatment in Patients With Bleeding From a Nonvariceal Upper Gastrointestinal Cause: A Randomized Controlled Trial.
- Author
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Lau, James Y.W., Li, Rui, Tan, Chen-huan, Sun, Xiu-jing, Song, Hao-jun, Li, Lan, Ji, Feng, Wang, Bu-jiang, Shi, Dong-tao, Leung, Wai K., Hartley, Imogen, Moss, Alan, Yu, Karina Y.Y., Suen, Bing Y., Li, Peng, and Chan, Francis K.L.
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RANDOMIZED controlled trials , *GASTROINTESTINAL hemorrhage , *HEMORRHAGE - Abstract
The standard first-line treatment for nonvariceal upper gastrointestinal bleeding is thermal coagulation therapy or through-the-scope hemostatic clips, with or without injection therapy. Over-the-scope clips (OTSCs) are generally used for recurrent or refractory bleeding. This trial compared OTSCs with standard endoscopic hemostatic treatment as first-line therapy for nonvariceal upper gastrointestinal bleeding. Visual Abstract. Use of Over-the-Scope Clips in Nonvariceal Upper Gastrointestinal Bleeding.: Nonvariceal upper gastrointestinal bleeding is a common clinical problem. The standard first-line treatment involves endoscopic bleeding control using either thermal coagulation therapy or through-the-scope hemostatic clips, with or without injection therapy. Over-the-scope clips have generally been used in the setting of recurrent or refractory bleeding. The objective of this randomized controlled trial from Hong Kong was to compare over-the-scope clips with standard endoscopic hemostatic treatment as first-line therapy in controlling nonvariceal upper gastrointestinal bleeding. Background: 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. Objective: To compare OTSCs with standard endoscopic hemostatic treatments in the control of bleeding from nonvariceal upper gastrointestinal causes. Design: A multicenter, randomized controlled trial. (ClinicalTrials.gov: NCT03216395) Setting: University teaching hospitals in Hong Kong, China, and Australia. Patients: 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Intervention: Standard hemostatic treatment (n = 97) or OTSC (n = 93). Measurements: 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. Results: 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]; P = 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]). Limitation: Clinicians were not blinded to treatment and the option of crossover treatment. Conclusion: 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. Primary Funding Source: General Research Fund to the University Grant Committee, Hong Kong SAR Government. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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