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临床试验/jRCT1042240025
jRCT1042240025招募中不适用

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

未提供0 个研究点目标入组 1,700 人开始时间: 2024年11月8日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,700
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Other
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 80age old under(—)
性别
All

入选标准

  • (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 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
  • (11) Endoscopic surveillance for 3 years after registration is considered feasible.
  • (12) Provision of written informed consent for participation in the trial.

排除标准

  • (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.

结局指标

主要结局

-

Targeted ESCC-free survival

次要结局

未报告次要终点

研究者

发起方
未提供

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