Endoscopic ablation therapy for superficial esophageal squamous cell carcinoma

JRCT ID: jRCT1052220106

Registered date:16/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: superficial esophageal squamous cell carcinoma
• Date of first enrollment: 06/10/2022
• Target sample size: 27
• Study type: Interventional
• Intervention(s): Ablation therapy for target lesion using endoscopic hemostasis forceps

Outcome(s)

• Primary Outcome: CR ratio estimated by follow-up endoscopy 12 months after ablation therapy

Secondary Outcome

CR ratio diagnosed by follow-up endoscopy 3 months after ablation
CR ratio of initial ablation estimated by follow-up endoscopy 12 months after ablation therapy
Adverse events
Incidence of metachronous cancer
Incidence of metastatic cancer
Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Histologically diagnosed squamous cell carcinoma or suspicion of squamous cell carcinoma diagnosed by preoperative endoscopy
Flat morphology (0-IIa, 0-IIb or 0-IIc)
Lesions of 2 cm or lesser in diameter
Lesions with submocosal fibrosis or stenosis due to previous treatment including endoscopic resection and chemoradiotherapy
cEP/LPM or cMM/SM1 of invasion depth diagnosed by preoperative endoscopy
Lesion of 2 cm or more apart from other lesions
No metastatic lesions diagnosed by CT examination
Age is 18 or over
No severe organ dysfunction
Performance Status (ECOG) is 0, 1 or 2
Written informed consent are obtained

Exclude criteria

Close to another lesion within 2 cm
Lesons considered to be able to be resected by ESD or EMR safely
Severe psychiatric disease
Active infectious disease
Participating in other interventional study
Patients judged inappropriate by investigator or attending doctor

Related Information

• Primary Sponsor: Ishihara Ryu
• Secondary ID(s): n/a