EDA Hospital
Kaohsiung City, 82445, Taiwan
Location status: Recruiting
NCT Number: NCT03183115
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.
Interested in participating?
Request Info20 year–90 year
All sexes
Interventional
Not applicable
Kaohsiung City, 82445, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HALO360 System (Covidien GI Solutions, Sunnyvale, California, USA), which has been approved by the US Food and Drug Administration (FDA) and is approved for use in Europe (CE mark) and Taiwan (Ministry of Health and Welfare). Because the HALO 360 balloon catheter has been phased out since 2019, a new Barrx™ 360 Express catheter was used thereafter.
The participants will receive meticulous endoscopic examination with Lugol chromoendoscopy and Narrow-band imaging
Before the RFA intervention, the participants will received Lugol staining over the esophagus
Time frame: From date of randomization until the date of first documented tumor recurrence, assessed up to 100 months
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.
Time frame: From date of intervention until the date of first documented adverse events, assessed up to 12months
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.
Contact information is provided by the study sponsor or research team.
Ching-Tai Lee, M.D.
CONTACT
886-7-6150011 ext. 251205
Wen-Lun Wang, Ph.D
CONTACT
886-7-6150011 ext. 251346
E-DA Hospital
Other
Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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