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

Segmentectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842578
• Other study ID #: thin cross- section of CT ZYP
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: The Second Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Segmentectomy
• Thin Cross- Section of CT
• Three-dimensional-computed Tomography (3D-CT)
• Video- Assisted Thoracoscopic Surgery

Intervention

Other:
• Cross- Section of CT Guided Anatomic Segmentectomy
The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.
• 3D simulation Guided Anatomic Segmentectomy
The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.

Locations

Country	Name	City	State
China	The Second Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	time before surgery (days)	days before surgery after being hospitalized	from the day of being hospitalized to the day of surgery, within 5 days
Primary	operation time (minutes)	the duration of the operation time	from beginning to the end of surgery, up to 180 minutes
Primary	confirmation time during surgery (number)	review time of the 3D reconstruction or the thin cross- section of CT during surgery	Intraoperative
Primary	air leakage after surgery (days)	the days of air leakage after surgery	within 7 days after surgery
Primary	the incidence of pneumonia (percentage)	the incidence of pneumonia after surgery	within 7 days after surgery
Primary	the incidence of atelectasis (percentage)	the incidence of atelectasis after surgery	within 7 days after surgery
Primary	Intraoperative bleeding (ml)	bleeding during anatomic segmentectomy, through the operation, an average of 100 ml	Intraoperative
Primary	Chest tube duration (days)	Chest tube duration after surgery	within 7 days after surgery
Primary	Postoperative hospital stay (days)	hospital stay after surgery	within 7 days after surgery