esophageal squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
Shizuoka Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with histologically confirmed squamous cell carcinoma or clinically diagnosed esophageal squamous cell carcinoma. 2. Clinical T1 esophageal cancer where B2 vessels are observed but B3 vessels are not observed. 3. The part where B2 vessels are observed is diagnosed as the deepest part of the tumor. 4. The main occupation site of the tumor is the cervical, thoracic, or abdominal esophagus (UICC-TNM 8th edition). 5. The maximum diameter of the tumor is 50 mm or less. 6. Patients who wish to undergo endoscopic or surgical resection as initial treatment. However, only those without planned preoperative chemotherapy for overlapping head and neck or gastric cancer cases are eligible. 7. No simultaneous esophageal advanced cancer. 8. No history of surgical esophagectomy. 9. No history of radiation therapy to the esophagus, lung field, or mediastinum, including treatment for other cancer types. 10. Past endoscopic resection for esophageal cancer is not a concern. However, if the lesion is located within 10mm of the scar from previous treatment, the patient is ineligible. 11. The age at registration is 18 years or older. 12. Performance status (PS) is assessed according to the ECOG criteria and is between 0 and 2. 13. The patient has provided written consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic infections requiring treatment. 2. Women who are pregnant, may be pregnant, or are breastfeeding. 3. Patients with psychiatric disorders, psychiatric symptoms, or cognitive impairments that make participation in the trial difficult. 4. Patients deemed inappropriate by the registering physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy (the proportion of cases where the preoperative depth diagnosis matches the histological depth diagnosis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ratio of pSM2-3 when the size of the area where B2 vessels are observed is 10 mm or more 2. Ratio of pSM2-3 when the macroscopic type of the area where B2 vessels are observed is 0-I or 0-III 3. Ratio of pSM2-3 when the size of the area where B2 vessels are observed is 10 mm or more, or the macroscopic type is 0-I or 0-III 4. Ratio of pEP/LPM when the size of the area where B2 vessels are observed is 4 mm or less 5. Positive predictive value 6. Sensitivity 7. Specificity 8. Likelihood ratio 9. Correlation between the size of the B2 vascular area and the histological depth 10. Correlation between the number of B2 vascular areas and the histological depth 11. Relationship between the macroscopic type of the B2 vascular area and the histological depth | — |
Countries
Japan
Contacts
Public ContactMasao Yoshida
Shizuoka Cancer Center Division of Endoscopy
Outcome results
None listed