Esophageal Squamous Cell Neoplasm Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 30, 2026 |
| Est. primary completion date | October 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 90 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | EDA Hospital | Kaohsiung City |
| Lead Sponsor | Collaborator |
|---|---|
| E-DA Hospital | National Taiwan University Hospital |
Taiwan,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From date of randomization until the date of first documented tumor recurrence, assessed up to 100 months | |
| Secondary | 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. | From date of intervention until the date of first documented adverse events, assessed up to 12months |