The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Segmentectomy; Video- Assisted Thoracoscopic Surgery; Three-dimensional-computed Tomography (3D-CT); Thin Cross- Section of CT
• Intervention / Treatment: Other: Cross- Section of CT Guided Anatomic Segmentectomy; Other: 3D simulation Guided Anatomic Segmentectomy

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • The Second Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group of thin cross- section of CT; Anatomic Segmentectomy with the Guidance of Thin Cross- Section of CT	Other: Cross- Section of CT Guided Anatomic Segmentectomy; The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.
Active Comparator: group of thin 3D simulation; Anatomic Segmentectomy with the Guidance of 3D simulation	Other: 3D simulation Guided Anatomic Segmentectomy; The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
planning time (minutes)	the planning time for anatomic segmentectomy before surgery, including the time- cost of the decision making and the planning time for surgery	from the first time of thin cross- section of CT is presented to the end of surgery, within 7 days
time before surgery (days)	days before surgery after being hospitalized	from the day of being hospitalized to the day of surgery, within 5 days
operation time (minutes)	the duration of the operation time	from beginning to the end of surgery, up to 180 minutes
confirmation time during surgery （number）	review time of the 3D reconstruction or the thin cross- section of CT during surgery	Intraoperative
air leakage after surgery (days)	the days of air leakage after surgery	within 7 days after surgery
the incidence of pneumonia （percentage）	the incidence of pneumonia after surgery	within 7 days after surgery
the incidence of atelectasis （percentage）	the incidence of atelectasis after surgery	within 7 days after surgery
Intraoperative bleeding (ml)	bleeding during anatomic segmentectomy, through the operation, an average of 100 ml	Intraoperative
Chest tube duration (days)	Chest tube duration after surgery	within 7 days after surgery
Postoperative hospital stay (days)	hospital stay after surgery	within 7 days after surgery

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University
• Investigators: Study Director: Xiaogang Zhao, The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: thin cross- section of CT ZYP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No