DM Jensen et al. Clin Gastroenterol Hepatol 2021; 19: 2315-2323. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding
Editorial: NS Buttar et al. Clin Gastroenterol Hepatol 2021; 19: 2266-2269. Full Text -Open Access: Silencing the Erupter: Over-the-Scope Clip in the Management of Nonvariceal Upper Gastrointestinal Bleeding
Background: “The OTSC (Ovesco Endoscopy AG, Tubingen, Germany) is a flexible, biocompatible nitinol clip that has multiple teeth oriented like a bear-claw, deployed via a band ligation–type mechanism. It is substantially larger than standard 2-tined hemostatic clips, allowing 1 OTSC to entrap far more tissue in a full-thickness bite. This unique design and its marked compressive force are purportedly capable of clinching even large vessels in excavated/fibrotic/near-perforating ulcers that are in complex anatomic locations. The bear-claw design allows not only for better tissue capture, but also adds higher site stability.”
53 patients (from cohort of 346) met the following criteria:
- (1) clinical instability (hypotension, shock, syncope, tachycardia, melena, hematemesis, and/or hematochezia)
- (2) laboratory evidence of high-volume blood loss (hemoglobin level ≤9 g/dL, or hemoglobin level decrease of ≥2 g/dL from baseline at admission)
- (3) need for packed red blood cell (PRBC) transfusion (received 1 or more units PRBC)
In this study, the authors compared OTSC to standard treatment (hemoclips or multipolar electrocoagulation).
Key findings from study:
- Immediate hemostasis was achieved in all patients.
- The cumulative 30-day rebleeding rate was significantly lower in the OTSC group than in the standard group (4% vs 28.6%; P = .017), with most patients experiencing rebleeding within 4 days. All rebleeds occurred in patients with major stigmata of recent hemorrhage (SRH) and none with lesser SRH. SRH included active spurting bleeding, visible vessel, or clot.
- The number of PRBC units transfused was also significantly higher in the standard versus OTSC group (0.68 vs 0.04 units; P = .03).
- Severe complications were less frequent in OTSC (0 % vs. 14.3%)
- Limitations: despite randomization, within the groups, major SRH with active arterial bleeding (Forrest 1A) was observed in a higher number of patients in the standard group (7 standard vs 2 OTSC) and study was conducted in specialized quaternary medical center with high expertise. In addition, “whether it should be used in all cases of NVUGIB or be reserved for patients with a high-risk for adverse outcome lesions12 remains to be addressed.”
- The editorial reviewed two other studies supporting the superiority of OTSC: FLETRock and STING.
My take (from editorial): The data about improved outcomes in the OTSC compared with standard therapy are compelling. Training in OTSC application will be needed for more widespread adoption.
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