EVEREST trial

JRCT ID: jRCT1042240025

Registered date:10/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal squamous cell carcinoma
• Date of first enrollment: 10/05/2024
• Target sample size: 1700
• Study type: Interventional
• Intervention(s): Patients after endoscopic resection of ESCC are divided into two groups for endoscopic surveillance: iodine staining after Narrow-band imaging (NBI) and NBI alone.

Outcome(s)

• Primary Outcome: Targeted ESCC-free survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Upper gastrointestinal endoscopy for surveillance after endoscopic resection of histopathologically diagnosed primary esophageal squamous cell carcinoma (ESCC) is planned.
(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 cervicothoracic region, 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.

Exclude 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.

Related Information

• Primary Sponsor: Yoshio Toshiyuki