PROSPECTIVE SINGLE-ARM TRIAL OF TWO-WEEK RABEPRAZOLE TREATMENT FOR ULCER HEALING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION

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Abstract

Aim:

Endoscopic submucosal dissection (ESD) causes artificial ulcers, and there is no consensus regarding the degree of healing in ESD-induced ulcers or the optimal duration of proton pump inhibitor (PPI) treatment. The aim of the present study was to investigate the healing rates of post-ESD ulcers in response to the protective effect of 2-week PPI treatment.

Methods:

Between February 2007 and March 2010, 75 patients/75 lesions and 55 patients/55 lesions were enrolled as interim and per-protocol groups, respectively. All patients were prescribed rabeprazole (10 mg/day) orally for 16 days beginning on the day before ESD. Follow-up endoscopy was carried out 8 weeks after ESD to evaluate ulcer healing. The primary end-point was the healing rate of post-ESD ulcers at 8 weeks after ESD. Secondary end-points were the rate of post-ESD bleeding with emergency endoscopy and the rate of other severe adverse effects during the study period.

Results:

The transitional rate to scarring-stage ulcers was 80.0% (44/55). Location in the lesser curve and large resected size (>40 mm) were statistically significant predictors for delayed ulcer healing by univariate analysis and the latter was still significant by the multivariate analysis. Post-ESD bleeding occurred within 2 weeks in two cases (2.7%), but both cases were successfully managed with endoscopic hemostasis only. Severe adverse effects did not occur.

Conclusions:

Two-week administration of PPI for post-ESD gastric ulcers may be sufficient to aid healing without increasing any adverse effects in cases where there are no possible deteriorating factors on ulcer healing, although large resection and/or resection in the lesser curve may result in delayed healing even after 8 weeks of ESD.

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