Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study

  • End date
    Dec 30, 2026
  • participants needed
  • sponsor
    E-DA Hospital
Updated on 24 October 2022


Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs) detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc resection of the neoplasia, and the resected specimen allows for a pathological assessment to evaluate the curability. However, the patients who received complete ESD for early ESCNs frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at 5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was 10%. Among them, those with "speckled" lugol staining pattern over the esophageal background mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue is gaining attention in the era of endoscopic treatment, but currently there was no appropriate strategy to prevent the tumor recurrence in these high-risk subjects.

Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs. To search a best strategy for the prevention of ESCNs, the investigators thus propose a hypothesis that the preemptive RFA for esophageal "speckled" lugol background mucosa may prevent the metachronous neoplastic recurrence after complete endoscopic resection.

Condition Esophageal Squamous Cell Neoplasm
Treatment Radiofrequency ablation, Endoscopy, Lugol's Solution (1.5%)
Clinical Study IdentifierNCT03183115
SponsorE-DA Hospital
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

Adults with early stage ESCNs (squamous high grade dysplasia, carcinoma in situ, or T1N0M0 SCC) who were treated by endoscopic submucosal dissection
Lugol staining showed "speckled" (>10 small lugol-unstained lesions) pattern of background mucosa

Exclusion Criteria

Having a history of incomplete endoscopic treatment, or complications during/after treatment (perforation, stricture)
Having history of systemic chemotherapy or radiation therapy for esophagus or post esophagectomy
Life expectancy <2 yr
Decompensated cirrhosis (Child score B, C)
Having large esophageal varices
Poor performance status (ECOG>2)
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