esophageal squamous cell carcinoma
Conditions
Interventions
Patients after endoscopic resection of ESCC are divided into two groups for endoscopic surveillance: iodine staining after Narrow-band imaging (NBI) and NBI alone.
Sponsors
Yoshio Toshiyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Upper gastrointestinal endoscopy for surveillance after endoscopic resection of histopathologically diagnosed primary esophageal squamous cell carcinoma (ESCC) is planned or already started. (2) Histopathology of all endoscopic resections was pT1a, negative for lymphovascular invasion, and negative for vertical margin. (3) The previous upper gastrointestinal endoscopy with iodine staining of the entire esophagus was performed within 6 months, and all histopathologically diagnosed ESCCs were endoscopically resected. (4) Additional treatment is not planned after endoscopic resection of ESCC. (5) No previous treatment for ESCC other than endoscopic resection. (6) No previous radiation therapy for the chest, lung field, or mediastinum for any cancer types. (7) No previous surgery for the esophagus or mediastinum including for benign tumors. (8) No pharyngeal or esophageal stricture where the standard endoscope cannot pass. (9) Age between 18 and 80 years. (10) An Eastern Cooperative Oncology Group Performance Status of 0 or 1. (11) Endoscopic surveillance for 3 years after registration is considered feasible. (12) Provision of written informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: (1) Other primary cancers within the previous 5 years except intramucosal tumors cured with local therapy. (2) A history of iodine allergy. (3) Severe mental disease. (4) The investigator considered ineligible as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Targeted ESCC-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of targeted ESCCs at 3 years Overall survival Disease-specific survival Multiple ESCC-free survival Cumulative incidence of multiple ESCCs at 3 years Cumulative incidence of ESCCs with lymphovascular invasion or SM invasion at 3 years Clinicopathological characteristics of multiple ESCCs Esophageal observation time Incidence of adverse events Incidence of heartburn, esophageal pain, or nausea | — |
Contacts
Public ContactTatsunori Minamide
Shizuoka Cancer Center (IMSUT Hospital -The Institute of Medical Science, The University of Tokyo)
Outcome results
None listed