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

NCT04842578 | Completed DMC

• 1 other identifier: thin cross- section of CT ZYP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

group of thin cross- section of CT

EXPERIMENTAL

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

Other: Cross- Section of CT Guided Anatomic Segmentectomy

group of thin 3D simulation

ACTIVE COMPARATOR

Anatomic Segmentectomy with the Guidance of 3D simulation

Other: 3D simulation Guided Anatomic Segmentectomy

Interventions

Cross- Section of CT Guided Anatomic Segmentectomy OTHER

The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.

group of thin cross- section of CT

3D simulation Guided Anatomic Segmentectomy OTHER

The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.

group of thin 3D simulation

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

Study Officials

• Xiaogang Zhao

  The Second Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 13, 2021
• Study Start: September 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CN (1)