Clinical trial NCT04842578: The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy
Official title: The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy With or Without 3-dimensional Computed Tomography Lung Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Segmentectomy
Video- Assisted Thoracoscopic Surgery
Three-dimensional-computed Tomography (3D-CT)
Thin Cross- Section of CT
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

(I) patients with insufficient cardiopulmonary function;

(II) other contraindication for segmentectomy.

Primary outcomes:
measure: planning time (minutes)
timeFrame: from the first time of thin cross- section of CT is presented to the end of surgery, within 7 days
measure: time before surgery (days)
timeFrame: from the day of being hospitalized to the day of surgery, within 5 days
measure: operation time (minutes)
timeFrame: from beginning to the end of surgery, up to 180 minutes
measure: confirmation time during surgery （number）
timeFrame: Intraoperative
measure: air leakage after surgery (days)
timeFrame: within 7 days after surgery
measure: the incidence of pneumonia （percentage）
timeFrame: within 7 days after surgery
measure: the incidence of atelectasis （percentage）
timeFrame: within 7 days after surgery
measure: Intraoperative bleeding (ml)
timeFrame: Intraoperative
measure: Chest tube duration (days)
timeFrame: within 7 days after surgery
measure: Postoperative hospital stay (days)
timeFrame: within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Xiaogang Zhao
role: STUDY_DIRECTOR
References: