An interventional study of Radiofrequency ablation and Endoscopy in Esophageal Squamous Cell Neoplasm, sponsored by E-DA Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-03.
Sponsored by E-DA Hospital · Not applicable, Interventional, and Prevention
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →E-DA Hospital is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Balloon type RFA (12J/cm2, 1 application) will be applied for the entire speckled esophageal mucosa at the 3 months after complete ESD. Oral prednisolone 30mg/day will be prescribed at day 3 after RFA procedure and continue for 28 days to prevent the post-RFA stenosis.
Procedure: Radiofrequency ablation · Device: Endoscopy · Drug: Lugol's Solution (1.5%)
No intervention; surveillance endoscopy alone
HALO360 System (Covidien GI Solutions, Sunnyvale, California, USA), which has been approved by the US Food and Drug Administration (FDA) and is approved for use in Europe (CE mark) and Taiwan (Ministry of Health and Welfare). Because the HALO 360 balloon catheter has been phased out since 2019, a new Barrx™ 360 Express catheter was used thereafter.
The participants will receive meticulous endoscopic examination with Lugol chromoendoscopy and Narrow-band imaging
Before the RFA intervention, the participants will received Lugol staining over the esophagus
Tumor recurrence
Metachronous tumor recurrence is defined as a tumor (high-grade dysplasia or squamous cell carcinoma) recurring at a new site after more than 6 months of complete remission status.
Time frame: From date of randomization until the date of first documented tumor recurrence, assessed up to 100 months
Major adverse events
including perforation, dysphagia, stenosis, defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis, or others resulting in the patients intolerable and discontinued intervention.
Time frame: From date of intervention until the date of first documented adverse events, assessed up to 12months
Plan to share: Undecided — The initial outcome and the data of adverse events will be shared with other researchers, by mail, when they are available.
Started Apr 2016 (actual). Primary completion is estimated for Oct 2025, 114 months after the start.
Of 209 non-industry interventional studies with no phase under Esophageal Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 96. This study's planned 114 months is above that.
Counting every sponsor, half of 218 studies reached it within 46 months; a quarter within 23 and three quarters within 96.
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Studies of the drug tested here: Lugol's solution
E-DA Hospital