Endoscopic background mucosal resurfacing to prevent metachronous recurrence of superficial esophageal squamous cell cancer after curative endoscopic submucosal dissection: randomized pilot study with 5-year follow-up (with video).

BACKGROUND AND AIMS

Metachronous 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 endoscopic background mucosa (ie, speckled pattern). We conducted a randomized controlled trial to investigate whether endoscopic radiofrequency ablation (RFA) for endoscopic background mucosal resurfacing (EBMR) can decrease the rate of metachronous neoplasia.

METHODS

Patients 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 receive either 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 to 3 months after ESD. The primary outcome was the metachronous recurrence of squamous neoplasia during a 5-year follow-up period. Secondary outcomes were major adverse events.

RESULTS

Of 112 patients screened, 30 were randomized to receive EBMR (n = 15) or surveillance (n = 15). The mean procedure time of EBMR was 30.7 minutes (range, 25-40). 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 = .001), with a number needed to treat of 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.

CONCLUSIONS

In this randomized trial of patients with multiple small LVLs over the endoscopic 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.).