NCT03183115Recruiting
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection
Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 3 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 May 2017
- Start date
- 18 Apr 2016
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- E-DA Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03183115
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 18 Apr 2016 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Life expectancy \<2 yr.
- Decompensated cirrhosis (Child score B, C).
- Having large esophageal varices.
- Poor performance status (ECOG\>2).
Who the study is looking for
- 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.
Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| EDA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.