Using radiofrequency ablation to prevent recurrence of esophageal cancer after surgery
Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | E-DA Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT03183115 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the use of RFA in this context is gaining attention, it remains a relatively novel approach with limited prior studies demonstrating success.
Eligibility criteria
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 this trial is running
Kaohsiung City
- EDA Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Wen-Lun Wang, Ph.D
- Email: warrengodr@gmail.com
- Phone: 886-7-6150011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.