BACKGROUND

There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)-induced ulcers.

OBJECTIVE

To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing.

DESIGN

Randomized, prospective, controlled study; clinical trial.

SETTING

Five hospitals in a University Medical Center group in Korea.

PATIENTS

This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer.

INTERVENTION

PPI and rebamipide combination therapy.

MAIN OUTCOME MEASUREMENTS

The ulcer healing rate at 4 weeks after ESD.

RESULTS

The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P < .0001) and in the per-protocol analysis (94.5% vs 91.2%; P = .020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P = .014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P = .027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P = .027; OR 1.933; 95% CI, 1.074-3.481).

LIMITATIONS

Open-label study.

CONCLUSION

PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT01167101.).