NIPH Clinical Trials Search

JRCT ID: jRCT1042240025

Registered date:10/05/2024


Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedesophageal squamous cell carcinoma
Date of first enrollment10/05/2024
Target sample size1700
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeTargeted ESCC-free survival
Secondary OutcomeCumulative 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
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


Public contact
Name Tatsunori Minamide
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center
Scientific contact
Name Toshiyuki Yoshio
Address 3-8-31 Ariake, Koto-ku, Tokyo Tokyo Japan 135-8550
Telephone +81-3-3520-0111
Affiliation Cancer Institute Hospital, Japanese Foundation for Cancer Research