NCT03183115

RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection

Recruiting now NA Last updated 3 March 2023

What this trial tests

NA trial testing Radiofrequency ablation in Esophageal Squamous Cell Neoplasm in 100 participants. Currently enrolling.

Timeline

18 April 2016

Primary endpoint
30 October 2025

30 December 2026

Quick facts

Lead sponsor	E-DA Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	18 April 2016
Primary completion	30 October 2025
Estimated completion	30 December 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• Radiofrequency ablation
• Endoscopy
• Lugol's Solution (1.5%) — full drug profile →

Conditions studied

• Esophageal Squamous Cell Neoplasm — all drugs for Esophageal Squamous Cell Neoplasm →

Sponsor

E-DA Hospital

Who can join

Adults 20 to 90, any sex, with Esophageal Squamous Cell Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Wang WL, Tsai YN, Hsu MH, Lin JT, et al · · 2025 · cited 5× · PMID 39521094 · DOI 10.1016/j.gie.2024.11.003
2. UEG Week 2023 Oral Presentations
   · 2023