jRCT1080225331已完成N/a
Cryoablation using the CryoBalloon Ablation System (CBAS) for superficial esophageal squamous cell carcinoma on or near the scar after endoscopic treatment: Efficacy and safety study
适应症
试验速览
- 阶段
- N/a
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of local complete response (L-CR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Non-blinded, Single-arm, Pivotal Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Eligibility criteria include, but are not limited to, the following:
- •Patients from whom written consent to participate in the study is obtained.
- •Patients aged greater than 20 years at the time of consent obtaining.
- •Patients with esophageal cancer who have been histologically diagnosed with squamous cell carcinoma.
- •Patients whose lesions are diagnosed on or near the scar after endoscopy treatment, whose lesions depth is within the mucosa, and for whose lesions ESD/EMR is technically difficult.
- •Patients having a lesion within thoracic or abdominal esophagus
- •Patients showing neither lymph node metastasis nor distant metastasis in image by CT at screening.
- •Patients who can pass through a therapeutic endoscope.
- •Patients with an ECOG Performance Status (PS) of 0 to 2 at the time of enrollment.
- •Patients who are judged to have enough organ functions based on laboratory values measured within 28 days before enrollment.
- •Patients who can follow up 12 months after primary cryoablation.
- •Women of childbearing potential who are negative in a urine pregnancy test agree to use contraception from obtaining informed consent through 6 months after the Cryoablation.
排除标准
- •Exclusion criteria including below but not limited to:
- •Diameter of lesion >50mm
- •Circumferential extent of target lesion is 360 degrees.
- •Patients whom a lesion targeted for treatment has more than 4 lesions
- •Patients whose Cryoablation treatment area is expected to cover the entire circumference.
- •Patients who has active multiple primary cancer.
- •Target tissue varices at risk for bleeding
- •Prior Heller myotomy
- •Patients who has serious complications such as Unstable angina, uncontrolled blood pressure, serious heart disease.
- •Patients with respiratory disease requiring oxygen administration.
- •Patients having serious complications
- •Pregnant or breastfeeding female patients.
- •Patients who are judged by the principal investigator as ineligible to be administered the Cryoablation, or in whom the principal investigator judges that treatment cannot be performed safely.
结局指标
主要结局
Rate of local complete response (L-CR)
时间窗: after 48 weeks from the Cryoablation
Judged in an independent committee
次要结局
- Rate of technically successful ablation
- Rate of local complete response (L-CR) judged the principal investigator or sub-investigator after 48 weeks from the Cryoablation(48 weeks from the Cryoablation)
- Rate of L-CR for all lesions
- Treatment time of the Cryoablation
- Pain score after the treatment
- Recurrence free survival
- Incidence rate of adverse event
- Overall survival
研究者
研究点 (1)
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