superficial esophageal squamous cell carcinoma Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histologically diagnosed squamous cell carcinoma or suspicion of squamous cell carcinoma diagnosed by preoperative endoscopy Flat morphology (0-IIa, 0-IIb or 0-IIc) Lesions of 2 cm or lesser in diameter Lesions with submocosal fibrosis or stenosis due to previous treatment including endoscopic resection and chemoradiotherapy cEP/LPM or cMM/SM1 of invasion depth diagnosed by preoperative endoscopy Lesion of 2 cm or more apart from other lesions No metastatic lesions diagnosed by CT examination Age is 18 or over No severe organ dysfunction Performance Status (ECOG) is 0, 1 or 2 Written informed consent are obtained
Exclusion criteria
Exclusion criteria: Close to another lesion within 2 cm Lesons considered to be able to be resected by ESD or EMR safely Severe psychiatric disease Active infectious disease Participating in other interventional study Patients judged inappropriate by investigator or attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR ratio estimated by follow-up endoscopy 12 months after ablation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| CR ratio diagnosed by follow-up endoscopy 3 months after ablation CR ratio of initial ablation estimated by follow-up endoscopy 12 months after ablation therapy Adverse events Incidence of metachronous cancer Incidence of metastatic cancer Overall survival | — |
Contacts
Department of Gastrointestinal Oncology, Osaka International Cancer Institute