JPRN-jRCTs031180099已完成3 期
Bronchoscopic lung mapping using dye and microcoil to resect small pulmonary lesions: an open-label, uncontrolled, single-arm multi-center study - VAL-MAP 2.0
Sato Masaaki0 个研究点目标入组 65 人开始时间: 2019年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
The present study achieved higher successful resection rate with sufficient margins (98.5%) than the primary goal (80%) set based on the result of previous studies, although the targeted lesions in this study was deeply located and highly challenging compared with those of previous studies. Furthermore, there was no clinically significant adverse events associated with the present technique of VAL-MAP. Taken together, VAL-MAP 2.0 is safe and effective to assist resection of deeply located pulmonary nodules.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Malignant pulmonary tumor (suspected or confirmed) that necessitates resection lines other than usual interlobar fissure
- •2) Corresponds to both 2-1 and 2-2
- •2-1) A pulmonary lesion or lesions that is anticipated to be hardly identifiable during surgery and necessitate careful determination of resection lines to obtain sufficient resection margins
- •2-2) A pulmonary lesion or lesions which the use of microcoil is considered to advantageous
- •3) Consent obtained from the patient
排除标准
- •1) Allergic to platinum
- •2) Allergic to indigo carmine
- •3) Anticipated difficulty in intra-airway placement of the microcoil
- •4) Pregnant women
- •5) Those who are difficult to obtain Informed Consent from or those aged less than 20 years old
- •6) Bronchoscopy and/or marking procedure is not feasible due to complications
- •7) Anatomy precludes successful resection defined in this study
- •8) Other reasons that are judged to be appropriate by a participating surgeon/physician in this study
研究者
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