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Received Oct 3, 2017; Accepted Dec 6, 2017
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1. Introduction
Endoscopic submucosal dissection (ESD), which was developed in Japan in the late 1990s, has been performed in many countries in recent years; with ESD, the 5-year survival rate of patients with early gastric cancer (EGC) exceeds 90% [1].
Several complications of ESD are known, the most important of which is post-ESD bleeding [2]. As ulcer healing prevents post-ESD bleeding, proton pump inhibitors (PPIs) are widely prescribed as the first-line therapy for artificial ulcers developing after ESD [3–5].
Recently, a novel potassium-competitive acid blocker (P-CAB) termed vonoprazan (TAKECAB; Takeda Pharmaceutical Co. Ltd., Tokyo, Japan) was developed. P-CAB exhibits a more powerful and longer antisecretory effect on H+/K+-ATPase than do PPIs. P-CAB was reported to be more effective than PPIs in the healing of gastroduodenal ulcers [6, 7]. Thus, P-CAB would be expected to afford better healing of artificial ulcers developing after ESD.
We began to investigate the effect of P-CAB on the healing of post-ESD artificial ulcers in March 2015 (trial UMIN000016835). To date, four comparative studies have examined the extent of artificial ulcer healing afforded by P-CAB compared with PPIs [8–11]. However, the results were controversial, and further work was required. Here, we examined the effects of vonoprazan compared with those of esomeprazole on the healing of post-ESD artificial ulcers in a prospective, multicenter, two-arm, randomized controlled trial (RCT) and found that the extent of healing of artificial ulcers after ESD was identical when either P-CAB or PPI was prescribed.
2. Methods
2.1. Study Design and Patients
We conducted a prospective study between May 2015 and May 2017 at two university hospitals (Yokohama City University Hospital, Yokohama, Japan, and Yokohama City University Medical Center, Yokohama, Japan). The study protocol was approved by the ethics review boards of both hospitals, and the trial was registered with the University Hospital Medical Information Network (number MIN000016835) and performed in accordance with the Declaration of Helsinki.
Patients diagnosed with EGC or gastric adenoma and treated via ESD at either hospital were recruited. We included patients...