A new hemostatic device for gastric endoscopic submucosal dissection: a prospective randomized controlled trial comparing Coajet and Hemograsper in Korea.

Background: Gastric endoscopic submucosal dissection (ESD) is often accompanied by bleeding. Coajet, a new device containing an injection needle, has been found to be useful in achieving hemostasis through monopolar contact. This study aimed to evaluate the efficacy and safety of this new hemostatic device by comparing it to hemostatic forceps (Hemograsper).

Methods: This prospective, randomized, single-center study enrolled consecutive patients scheduled to undergo gastric ESD from February 2022 to January 2023. The Hemograsper group (HG) underwent hemostasis using the conventional method, whereas the Coajet group (CG) used this new tool for lesion marking, submucosal injection in the initial stage of ESD, and then for hemostasis.

Results: A total 56 patients were enrolled in this study (HG, 28; CG, 28). No significant differences in age, sex, diagnosis, location, endoscopic size, or morphology were observed between the two groups. No significant difference in total operative time (HG, 16.0±6.9 minutes vs. CG, 12.4±6.7 minutes; p=0.05) and hemostatic time (HG, 186.6±134.5 seconds vs. CG, 130.4±81.5 seconds; p=0.06) were observed between the two groups. No differences in other procedure-related variables, such as complete en-bloc resection rate, length of admission, grade of immediate bleeding, and delayed bleeding within 30 days (HG, n=1 vs. CG, n=1), were noted.

Conclusions: The new hemostatic device, Coajet, showed comparable efficacy to that of conventional hemostatic forceps for bleeding control and the prevention of delayed bleeding in gastric ESD.