A randomized comparative trial of OTSC and Padlock for upper GI hemostasis in a standardized experimental setting

AbstractIntroduction: Upper gastrointestinal bleeding (UGIB) is the key emergency situation in clinical endoscopy and is traditionally treated with injection, thermal or through the scope clipping therapy. Mortality rates are in the range of 8–10% and demand new treatment approaches. The Over-The-Scope Clip (OTSC®) has been described as a very effective hemostatic device in UGIB. We compared OTSC with the Padlock™ device in an established pre-clinical setting.Material and methods: Our test-bed consisted of the biohybrid EASIE model using soft silicone tubes, tunneled into the gastric wall and surfacing at a mucosa defect, representing the bleeding site. After successful deployment of the OTSC and Padlock devices on the spurting ulcer bleed (Forrest Ia) the vessel tubes were pressurized with a manometer to 120 mmHg. Tight closure at this pressure was defined as successful hemostasis (primary endpoint). N = 11 procedures were done with each device. Statistical testing was done using Fisher’s exact test. Sam...