• LauJames Y WJYW0000-0003-0122-4068Prince 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.)., Rui Li, Chen-Huan Tan, Xiu-Jing Sun, Hao-Jun Song, Lan Li, Feng Ji, Bu-Jiang Wang, Dong-Tao Shi, Wai K Leung, Imogen Hartley, Alan Moss, Karina Y Y Yu, Bing Y Suen, Peng Li, and ChanFrancis K LFKL0000-0001-7388-2436Prince 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.)..
• 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.).
• Ann. Intern. Med. 2023 Apr 1; 176 (4): 455462455-462.

BackgroundCurrent 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.ObjectiveTo compare OTSCs with standard endoscopic hemostatic treatments in the control of bleeding from nonvariceal upper gastrointestinal causes.DesignA multicenter, randomized controlled trial. (ClinicalTrials.gov: NCT03216395).SettingUniversity teaching hospitals in Hong Kong, China, and Australia.Patients190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy.InterventionStandard hemostatic treatment (n = 97) or OTSC (n = 93).MeasurementsThe 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.ResultsThe 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]).LimitationClinicians were not blinded to treatment and the option of crossover treatment.ConclusionOver-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 SourceGeneral Research Fund to the University Grant Committee, Hong Kong SAR Government.

28 keywords...

hide…