577 Randomized Controlled Trial (RCT) of Over-the-Scope Clip (OTSC) as Initial Endoscopic Treatment of Severe Non-Variceal Upper Gastrointestinal Bleeding (NVUGIB)

Abstract

INTRODUCTION: Recurrent GI bleeding from peptic ulcers (PUB's) & Dieulafoy's lesions is common in high risk patients. In our recent RCT, patients treated with Standard Hemostasis- RX (e.g. hemoclips &/or multipolar probe with epinephrine pre-injection) for severe NVUGIB had a 30 day rebleed rate of 26.3 % (Gastro 2017;152:1310). OTSC obliterates arterial flow underneath stigmata of hemorrhage (SRH) of PUB's more effectively than Standard RX & residual blood flow correlates with rebleed risk (DDW 2019). No one has reported an RCT of OTSC as primary, initial treatment compared to current Standard RX. Therefore, we performed this RCT. METHODS: The RCT was conducted at 2 academic medical centers after IRB approvals & Clinicaltrials.gov registration (NCT03065465). After informed consent for emergency endoscopy (EGD), patients & their caregivers (general GI, ICU & primary care) were blinded as to EGD Rx & the latter MD's made all management decisions about medical treatment, RBC transfusions, or ordering repeat EGD or angiography (IR) for rebleeding. Patients who met clinical & EGD criteria for PUB's or UGI Dieulafoy's lesions (with major SRH or spots with arterial blood flow) were randomized in a 1:1 allocation to either Standard RX (as described in above RCT) or OTSC. All patients received high dose PPI's after randomization & were followed prospectively for 30 days. Clinical outcomes data were collected on standard forms, de-identified, entered onto computer files, managed with SAS, & analyzed by a biostatistician (JG). RESULTS: 49 RCT patients were well matched in demographics, risk factors, lesion type & SRH (Table 1). In contrast, the proportion of patients with 30 day rebleeding was significantly higher with Standard RX - 28% (7/25) - compared to OTSC Rx – 4.2% (1/24) - P = 0.0285 by Chi square (P = 0.022 by log rank test – See Figure 1). The OTSC rebleed rate was 85% lower than Standard group (Relative Risk 0.149 with 95% confidence intervals of 0.006, 0.863). The number needed to treat (NNT) was 4.2. See Table 2 for other outcomes. CONCLUSION: In patients with severe UGI bleeding from PUB's or Dieulafoy's lesions, primary endoscopic treatment with a large over the scope hemoclip resulted in significantly lower rates of rebleeding & severe complications, & fewer RBC transfusions than standard endoscopic hemostasis. Results appear to relate OTSC's superior ability to obliterate arterial blood flow underneath SRH & thereby reduce lesion rebleeding.