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

RecruitingNAAges 20 Years - 90 YearsAllE-DA Hospital
NCT03183115 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 E

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📋 Eligibility rules (as published)
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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What it tests

  • Radiofrequency ablation
  • Endoscopy
  • Lugol's Solution (1.5%)
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Where

1 site
EDA Hospital
Kaohsiung City, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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