BACKGROUND/AIMS: When a peptic ulcer is treated with proton pump inhibitors (PPI), protrusion of the ulcer base is sometimes noted during ulcer healing. To clarify the incidence of ulcer base protrusion in ulcers induced by endoscopic submucosal dissection (ESD), and whether the addition of polaprezinc, a cytoprotective agent used for treatment of gastric ulcer, to the PPI regimen helps to suppress it. METHODOLOGY:One hundred sixty-three patients on which ESD was performed were randomly allocated to either two groups: one treated with lansoprazole (30mg/day) and the other with lansoprazole (30mg/day) plus polaprezinc (150mg/day) for the treatment of ESD-induced ulcer. The condition of the ESD-induced ulcer was blindly assessed two months after ESD by two physicians. RESULTS:Lansoprazole plus polaprezinc group showed significantly better ulcer healing (p < 0.0001) and protrusion of the ulcer base was recognized in only 1.3% (1/77), an incidence significantly lower than that in lansoprazole group (20.7%, 16/77, p = 0.0001). Polaprezinc was the only significant factor (p = 0.0001) differentiating patients who had ulcer base protrusion (n = 17) from those who did not (n = 137). CONCLUSIONS:Polaprezinc prevents protrusion of the ulcer base during the healing of ESD-induced ulcer with PPI.
RCT Entities:
BACKGROUND/AIMS: When a peptic ulcer is treated with proton pump inhibitors (PPI), protrusion of the ulcer base is sometimes noted during ulcer healing. To clarify the incidence of ulcer base protrusion in ulcers induced by endoscopic submucosal dissection (ESD), and whether the addition of polaprezinc, a cytoprotective agent used for treatment of gastric ulcer, to the PPI regimen helps to suppress it. METHODOLOGY: One hundred sixty-three patients on which ESD was performed were randomly allocated to either two groups: one treated with lansoprazole (30mg/day) and the other with lansoprazole (30mg/day) plus polaprezinc (150mg/day) for the treatment of ESD-induced ulcer. The condition of the ESD-induced ulcer was blindly assessed two months after ESD by two physicians. RESULTS:Lansoprazole plus polaprezinc group showed significantly better ulcer healing (p < 0.0001) and protrusion of the ulcer base was recognized in only 1.3% (1/77), an incidence significantly lower than that in lansoprazole group (20.7%, 16/77, p = 0.0001). Polaprezinc was the only significant factor (p = 0.0001) differentiating patients who had ulcer base protrusion (n = 17) from those who did not (n = 137). CONCLUSIONS: Polaprezinc prevents protrusion of the ulcer base during the healing of ESD-induced ulcer with PPI.