Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
EDA Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Wen-Lun Wang, Ph.D
warrengodr@gmail.com
886-7-6150011
Backup
Ching-Tai Lee, M.D.
fattoo@gmail.com
886-7-6150011
Time Frame
Start Date: 2016-04-18
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
Experimental: RFA group
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.
No_intervention: Control group
No intervention; surveillance endoscopy alone
Related Therapeutic Areas
Sponsors
Leads: E-DA Hospital
Collaborators: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov