A RANDOMIZED CONTROL STUDY EVALUATING THE EFFICACY OF A HEMOSTATIC POWDER (UI-EWD) IN DECREASING THE RATE OF UPPER GASTROINTESTINAL RE-BLEEDING IN PATIENTS TREATED WITH ENDOSCOPIC THERAPY FOR HIGH-RISK LESIONS

Background & Aim:
Non-variceal upper gastrointestinal bleeding (NVUGIB) accounts for a significant number of patient visits to emergency rooms and remains a major cause of mortality and morbidity worldwide. The re-bleeding rates of NVUGIB after endoscopic treatment within 72 hours have been reported to be up to 25%. re-UI-EWD is a newly developed novel endoscopic hemostatic powder UI-EWD(UI-EWD) that forms an adhesive hydropolymer when sprayed on the surface of the gastrointestinal tract. The aim of this study was to evaluate efficacy of UI-EWD on decreasing the re-bleeding rate after standard endoscopic treatment (SET) of acute NVUGIB.
Methods:
This prospective, multicenter, randomized controlled trial was conducted from December 2018 to November 2021. Consecutive patients with acute NVUGIB from high-risk lesions (Forrest classification Ia, Ib, and IIa) who achieved immediate hemostasis through SET were randomized in a 1:1 ratio to UI-EWD powder (P) with SET group (SET+P, test) vs SET only group (SET, control). Primary outcomes were defined as re-bleeding rate within 72 hours following treatment and secondary outcomes were re-bleeding rate within 30 days following treatment, as well as safety of UI-EWD.
Results:
A total of 348 patients were randomized into the test (n=175) vs control (n=173) groups. Baseline characteristics were not statistically different between groups. The classification of lesion type (test vs control: Forrest Ia and Ib, 115(66.8%) vs 113(67.3%), p=0.831), Glasgow-Blatchford bleeding score (test vs control: 10.7 vs 10.4, p=0.589) was not statistically different between groups. Re-bleeding rate within 3 days was statistically significantly lower in the test group than in the control group (2.9% (n=5) vs 11.3% (n=19), p=0.005). The 30-day cumulative re-bleeding rate was also lower in the test group than in the control group [7.0% (n=12) vs 18.5% (n=31), p=0.003] There was no reported UI-EWD related adverse events such as perforation, bowel obstruction, or gas embolization during the study period.
Conclusion:
This study demonstrates that UI-EWD application following SET significantly reduced 3-day and 30-day re-bleeding rates in patients treated for NVUGIB without any adverse reactions.