The use of diluted epinephrine during gastric endoscopic submucosal dissection: an international randomized controlled trial.

BACKGROUND AND AIMS Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric cancer. Intraprocedural bleeding during gastric ESD may result in prolonged procedure time. Therefore, we investigated the efficacy of adding diluted epinephrine to a submucosal injection solution to reduce the procedure time in gastric ESD.

METHODS This international, multicenter, randomized controlled trial was conducted across 12 institutions. Patients with gastric mucosal neoplasia, who underwent ESD, were eligible. The patients were randomly allocated to either the epinephrine group (1:100,000 diluted epinephrine-added injection solution) or the control group. Randomization was stratified according to lesion location, size, and institution. Patients, endoscopists, and assessors were blinded to the treatment allocation. The primary outcome was the procedure time. Secondary outcomes included the number of intraprocedural hemorrhages requiring the use of hemostatic forceps and post-procedural adverse events.

RESULTS A total of 800 patients were enrolled, 774 of whom were included in the final modified intention-to-treat analysis. A total of 386 and 388 patients were randomized into the epinephrine and control groups, respectively. The mean (standard deviation) procedure time was significantly shorter in the epinephrine group than in the control group: 60 (46) vs. 68 (45) min, respectively (p = 0.018). The number of intraprocedural hemorrhages requiring hemostatic forceps was significantly lower in the epinephrine group (mean count: 1.8 vs 3.0; p < 0.001). There were no significant differences in post-procedural adverse events between the groups.

CONCLUSION The addition of diluted epinephrine to the injection solution significantly reduces the procedure time for gastric ESD. (ClinicalTrials.gov: NCT04032119).