53 patients with NVUGIB were randomized to OTSC hemostasis or standard endoscopic treatment. Rebleeding occurred in 4 % in OTSC group vs 28.6 % in standard group (p = 0.017), severe complications did not occur in OTSC group, but in 14.3 % of patients with standard endoscopic treatment, 0.04 units of red blood cell transfusions were needed in patients treated with OTSC post-randomization vs. 0.68 units in standard therapy group.
D.M. Jensen et al., CURE Digestive Diseases Research Core Center, Los Angeles, CA, USA, presented a randomized controlled trial (RCT) on initial endoscopic treatment of severe non-variceal upper gastrointestinal bleeding (NVUGIB) with OTSC compared to standard endoscopic hemostasis.
53 patients with bleeding ulcers or Dieulafoy’s lesions and major or lesser stigmata of hemorrhage were randomized to OTSC (n = 25) or endoscopic standard therapy (n = 28). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Major stigmata of recent hemorrhage were defined as active spurting or pulsatile arterial bleeding, non-bleeding visible vessel, or adherent clot. Lesser stigmata of recent hemorrhage were defined as oozing bleeding without clot or visible vessel or flat spot with arterial blood flow underneath, detected by Doppler probe. Standard endoscopic hemostasis was performed with hemoclips or multipolar electrocoagulation. After randomization all patients received high dose intravenous infusions of PPI (proton pump inhibitors) for 72 hours, followed by twice daily oral PPI for 27 days in patients with peptic ulcer bleedings.
Baseline patient characteristics and endoscopic findings were similar between the OTSC and the standard therapy group. However, patient outcomes showed significant differences in OTSC vs standard group in rates of rebleeding (4 % vs. 28.6 %; p = 0.017; relative risk 0.10, 95 % CI 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 stigmata of hemorrhage and none in patients with lesser stigmata of hemorrhage.
The authors concluded that OTSC significantly reduces rates of rebleeding, severe complications, and post-randomization red cell concentrate transfusions. Patients with major stigmata of hemorrhage benefit significantly from hemostasis with OTSC. Based upon these RCT results and those of the RCT by Schmidt A et al. (Gastroenterology 2018), current guidelines for standard endoscopic hemostasis of severe NVUGI hemorrhage should be re-evaluated and updated.
Randomized Controlled Trial of Over-the-Scope-Clip as Initial Treatment of Severe Non-Variceal Upper Gastrointestinal Bleeding
Jensen DM, Kovacs TOG, Ghassemi KA, Kaneshiro M, Gornbein J.
Clinical Gastroenterology and Hepatology (2020), doi: https://doi.org/10.1016/j.cgh.2020.08.046.