Using radiofrequency ablation to prevent recurrence of esophageal cancer after surgery
Official title: Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study
Run by E-DA Hospital · NCT03183115 · Data updated 2026-11-12
This study tests whether using radiofrequency ablation can help prevent new esophageal cancer from coming back in patients who have already had surgery for early-stage cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | E-DA Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kaohsiung City) |
| Status | Recruiting |
| Started | April 18, 2016 |
| Main results expected | October 30, 2025 |
| Study ends | December 30, 2026 |
| Registry record updated | March 3, 2023 |
| Trial ID | NCT03183115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with early-stage ESCNs who have undergone complete endoscopic submucosal dissection and exhibit a 'speckled' lugol staining pattern.
✕Probably not a fit
Patients who have had incomplete endoscopic treatment or those with a history of systemic chemotherapy or radiation therapy for esophageal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of radiofrequency ablation (RFA) to prevent the recurrence of metachronous squamous neoplasia in patients who have undergone complete endoscopic submucosal dissection (ESD) for early esophageal squamous cell neoplasms (ESCNs). The study focuses on patients with a specific 'speckled' lugol staining pattern, which indicates a higher risk for recurrence. By applying RFA, the trial aims to reduce the incidence of new tumors in these high-risk patients. The methodology includes careful monitoring of patients post-ESD and the application of RFA as a preventive measure.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in patients with early esophageal squamous cell neoplasms.
How similar studies have gone: While the use of RFA in this context is gaining attention, it remains a relatively novel approach with limited prior studies demonstrating success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
EDA Hospital
Kaohsiung City, Taiwan Recruiting
Study contacts
- Study coordinator: Wen-Lun Wang, Ph.D
- Email: warrengodr@gmail.com
- Phone: 886-7-6150011
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.