Actively Recruiting
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection
Led by E-DA Hospital · Updated on 2023-03-03
100
Participants Needed
1
Research Sites
558 weeks
Total Duration
On this page
Sponsors
E
E-DA Hospital
Lead Sponsor
N
National Taiwan University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with early stage esophageal squamous cell neoplasia (high grade dysplasia, carcinoma in situ, or T1N0M0 squamous cell carcinoma) treated by endoscopic submucosal dissection
- Presence of "speckled" pattern (more than 10 small Lugol-unstained lesions) on esophageal background mucosa by Lugol staining
You will not qualify if you...
- History of incomplete endoscopic treatment or complications such as perforation or stricture during or after treatment
- History of systemic chemotherapy or radiation therapy for esophagus or prior esophagectomy
- Life expectancy less than 2 years
- Decompensated cirrhosis (Child score B or C)
- Presence of large esophageal varices
- Poor performance status (ECOG score greater than 2)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
EDA Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
Research Team
W
Wen-Lun Wang, Ph.D
CONTACT
C
Ching-Tai Lee, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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