臨床研究等提出・公開システム

A randomized controlled trial of Endoscopic surVEillance with NBI or iodine staining for patients after Endoscopic RESecTion of esophageal squamous cell carcinoma

EVEREST trial

Yoshio Toshiyuki

Cancer Institute Hospital, Japanese Foundation for Cancer Research

3-8-31 Ariake, Koto-ku, Tokyo

toshiyuki.yoshio@jfcr.or.jp

Minamide Tatsunori

Shizuoka Cancer Center (IMSUT Hospital -The Institute of Medical Science, The University of Tokyo)

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

tminamide@ims.u-tokyo.ac.jp

Recruiting

May. 10, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

other

(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.

(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.

Both

esophageal squamous cell carcinoma

Patients after endoscopic resection of ESCC are divided into two groups for endoscopic surveillance: iodine staining after Narrow-band imaging (NBI) and NBI alone.

Targeted ESCC-free survival

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

+81-55-989-5222

Mar. 07, 2024

No

none