Actively Recruiting

Phase Not Applicable
Age: 20Years - 90Years
All Genders
NCT03183115

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

Age: 20Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

EDA Hospital

Kaohsiung City, Taiwan, 82445

Actively Recruiting

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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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