跳至主要内容
临床试验/NCT04842578
NCT04842578已完成不适用

The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy With or Without 3-dimensional Computed Tomography Lung Simulation

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
air leakage after surgery (days)

研究概览

简要总结

Three-dimensional (3D) simulation of pulmonary vessels and the space between the lesion and adjacent tissues is regarded improving the safety and accuracy of video-assisted thoracoscopic surgery (VATS) for segmentectomy for ground glass opacity (GGO) in lung. However, not every thoracic surgeon can handle the technique, in addition, the 3D reconstruction originate from the thin CT scan. Actually, the investigators found that, the reading and comprehension of the thin cross- section of CT can guide the accurate anatomic segmentectomy in most situations. The investigators designed a retrospective study to compare the reading of thin cross- section of CT with 3D reconstruction or without 3D reconstruction during the guidance of anatomic segmentectomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Selection criteria for VATS segmentectomy in the present study were as follows:
  • •(I) patients with single peripheral GGO lesion considered suspicious for malignancy;
  • •(II) the lesion <2 cm in diameter and with at least one of the followings:
  • •(i) pure adenocarcinoma in situ (AIS) histology;
  • •(ii) nodule has ≥50% ground-glass appearance on high resolution CT;
  • •(iii) radiologic surveillance conforms a long doubling time (≥400 days).

排除标准

  • •(I) patients with insufficient cardiopulmonary function;
  • •(II) other contraindication for segmentectomy.

研究组 & 干预措施

group of thin cross- section of CT

Experimental

Anatomic Segmentectomy with the Guidance of Thin Cross- Section of CT

干预措施: Cross- Section of CT Guided Anatomic Segmentectomy (Other)

group of thin 3D simulation

Active Comparator

Anatomic Segmentectomy with the Guidance of 3D simulation

干预措施: 3D simulation Guided Anatomic Segmentectomy (Other)

结局指标

主要结局

air leakage after surgery (days)

时间窗: within 7 days after surgery

the days of air leakage after surgery

the incidence of pneumonia (percentage)

时间窗: within 7 days after surgery

the incidence of pneumonia after surgery

the incidence of atelectasis (percentage)

时间窗: within 7 days after surgery

the incidence of atelectasis after surgery

Chest tube duration (days)

时间窗: within 7 days after surgery

Chest tube duration after surgery

time before surgery (days)

时间窗: from the day of being hospitalized to the day of surgery, within 5 days

days before surgery after being hospitalized

confirmation time during surgery (number)

时间窗: Intraoperative

review time of the 3D reconstruction or the thin cross- section of CT during surgery

operation time (minutes)

时间窗: from beginning to the end of surgery, up to 180 minutes

the duration of the operation time

planning time (minutes)

时间窗: from the first time of thin cross- section of CT is presented to the end of surgery, within 7 days

the planning time for anatomic segmentectomy before surgery, including the time- cost of the decision making and the planning time for surgery

Intraoperative bleeding (ml)

时间窗: Intraoperative

bleeding during anatomic segmentectomy, through the operation, an average of 100 ml

Postoperative hospital stay (days)

时间窗: within 7 days after surgery

hospital stay after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验