Background and AimsMetachronous recurrence frequently develops in patients with superficial esophageal squamous cell carcinomas (ESCCs) after curative endoscopic submucosal dissection (ESD), especially in those with multiple (>10) small Lugol-voiding lesions (LVLs) over the esophageal background mucosa (i.e. speckled pattern). We conducted a randomized controlled trial to investigate whether endoscopic radiofrequency ablation (RFA) for esophageal background mucosal resurfacing (EBMR) can decrease the rate of metachronous neoplasia. MethodsPatients who received curative ESD and whose Lugol staining showed a speckled pattern over the background mucosa were randomly assigned in a 1:1 ratio to either receive RFA (EBMR group) or endoscopic surveillance alone (control group). EBMR with RFA was performed with a balloon device for circumferential ablation of the total esophageal mucosa 2–3 months after ESD. The primary outcome was the metachronous recurrence of squamous neoplasia during a 5-year follow-up period. The secondary outcomes were major adverse events. ResultsOf 112 patients screened, 30 were randomized to receive EBMR (n = 15) or surveillance (n = 15). The mean procedure time of EBMR was 30.7 min (range: 25–40 min). One patient developed post-RFA stenosis, which resolved after 3 sessions of endoscopic dilation. EBMR reduced the risk of metachronous recurrence (0% in the EBMR group vs. 53% in the control group, p = 0.001), with the number needed to treat being 1.9. Reversal of the Lugol staining speckled pattern to only a few LVLs occurred in all patients and persisted for at least 5 years in the ablation group. ConclusionIn this randomized trial of patients with multiple small LVLs over the esophageal background after curative ESD, EBMR with balloon-type RFA is a promising and safe procedure for preventing metachronous recurrence over 5 years of follow-up. Clinical trial registration number: NCT03183115.
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