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NCT Number: NCT04842578

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

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.

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Key information

Conditions

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

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cross- Section of CT Guided Anatomic Segmentectomy

Other

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

3D simulation Guided Anatomic Segmentectomy

Other

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

Primary outcomes

  1. planning time (minutes)

    Time frame: 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

  2. time before surgery (days)

    Time frame: from the day of being hospitalized to the day of surgery, within 5 days

    days before surgery after being hospitalized

  3. operation time (minutes)

    Time frame: from beginning to the end of surgery, up to 180 minutes

    the duration of the operation time

  4. confirmation time during surgery （number）

    Time frame: Intraoperative

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

  5. air leakage after surgery (days)

    Time frame: within 7 days after surgery

    the days of air leakage after surgery

  6. the incidence of pneumonia （percentage）

    Time frame: within 7 days after surgery

    the incidence of pneumonia after surgery

  7. the incidence of atelectasis （percentage）

    Time frame: within 7 days after surgery

    the incidence of atelectasis after surgery

  8. Intraoperative bleeding (ml)

    Time frame: Intraoperative

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

  9. Chest tube duration (days)

    Time frame: within 7 days after surgery

    Chest tube duration after surgery

  10. Postoperative hospital stay (days)

    Time frame: within 7 days after surgery

    hospital stay after surgery

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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