Esophageal squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
AMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients undergoing EMR or ESD for esophageal cancer (initially treated cases or previously treated cases) 2) Complete endoscopic resection is judged to be feasible. 3) A histopathological diagnosis of esophageal squamous cell carcinoma on examination of resected specimens 4) Vertical margins confirmed to be negative on examination of resected specimens 5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after EMR or ESD. 6) The attending physician judges that 10 or more years of follow-up observations are possible. 7) Written informed consent is obtained directly from the patient.
Exclusion criteria
Exclusion criteria: 1) Registration in the JEC-1 study 2) A history of chemotherapy (including molecular targeted therapies) 3) A history of radiotherapy or surgical resection for head and neck cancer or esophageal cancer 4) Active double cancers in other organs (However, intramucosal cancers of other organs are not regarded to be active cancers in other organs.) 5) An allergy to iodine 6) Patients considered by their attending physicians to be unsuitable for enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative incidence of metachronous cancers in other organs according to the grade of LVL | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1) The total numbers of metachronous cancers arising in other organs per person-year according to the grade of LVL 2) The cumulative incidences of head and neck cancer and of gastric cancer according to the grade of LVL 3) The total numbers of head and neck cancers and of gastric cancers per person-year according to the grade of LVL 4) The cumulative incidences of metachronous cancers in other organs in patients who successfully quit drinking alcohol and those who did not 5) The cumulative incidences of metachronous cancers in other organs in patients who successfully quit smoking and those who did not 6) The cumulative incidences of metachronous cancer in other organs in patients who received initial treatment for esophageal cancer and patients with a history of previous treatment 7) The total numbers of metachronous cancers in other organs per person-year in patients who received initial treatment for esophageal cancer and patients with a history of previous treatment Other Analyses 1) Investigatory analysis of risk factors other than the grade of LVL for the development of metachronous cancer in other organs 2) Analysis of outcomes in enrolled patients (as compared with outcomes in the previous JEC-1 study) | — |
Countries
Japan
Contacts
Public ContactChikatoshi Katada
Kitasato University School of Medicine Department of Gastroenterology
Outcome results
None listed