SegmentectomyNCT04842578
The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy
A study testing Cross- Section of CT Guided Anatomic Segmentectomy and 3D simulation Guided Anatomic Segmentectomy in people with Segmentectomy and Video- Assisted Thoracoscopic Surgery, run by The Second Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Segmentectomy, Video- Assisted Thoracoscopic Surgery, Three-dimensional-computed Tomography (3D-CT)
- What is being tested?
- Cross- Section of CT Guided Anatomic Segmentectomy and 3D simulation Guided Anatomic Segmentectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Selection criteria for VATS segmentectomy in the present study were as follows:
- patients with single peripheral GGO lesion considered suspicious for malignancy;
- the lesion <2 cm in diameter and with at least one of the followings:
- pure adenocarcinoma in situ (AIS) histology;
- nodule has ≥50% ground-glass appearance on high resolution CT;
- radiologic surveillance conforms a long doubling time (≥400 days).
Who cannot join
- patients with insufficient cardiopulmonary function;
- other contraindication for segmentectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Segmentectomy, Video- Assisted Thoracoscopic Surgery, Three-dimensional-computed Tomography (3D-CT), Thin Cross- Section of CT
- Being tested
- Cross- Section of CT Guided Anatomic Segmentectomy, 3D simulation Guided Anatomic Segmentectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross- Section of CT Guided Anatomic SegmentectomyOther
The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.
3D simulation Guided Anatomic SegmentectomyOther
The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.
| Study group | Role | What they receive |
|---|---|---|
| group of thin cross- section of CT | Experimental | Anatomic Segmentectomy with the Guidance of Thin Cross- Section of CT Receives: Other: Cross- Section of CT Guided Anatomic Segmentectomy |
| group of thin 3D simulation | Active comparator | Anatomic Segmentectomy with the Guidance of 3D simulation Receives: Other: 3D simulation Guided Anatomic Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: from the day of being hospitalized to the day of surgery, within 5 days
operation time (minutes)
the duration of the operation time
Measured: 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
Measured: Intraoperative
air leakage after surgery (days)
the days of air leakage after surgery
Measured: within 7 days after surgery
the incidence of pneumonia （percentage）
the incidence of pneumonia after surgery
Measured: within 7 days after surgery
the incidence of atelectasis （percentage）
the incidence of atelectasis after surgery
Measured: within 7 days after surgery
Intraoperative bleeding (ml)
bleeding during anatomic segmentectomy, through the operation, an average of 100 ml
Measured: Intraoperative
Chest tube duration (days)
Chest tube duration after surgery
Measured: within 7 days after surgery
Postoperative hospital stay (days)
hospital stay after surgery
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Sep 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SegmentectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842578
- Sponsor's protocol ID
- thin cross- section of CT ZYP
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guidance of Thin Cross- Section of CT in Anatomic Segmentectomy With or Without 3-dimensional Computed Tomography Lung Simulation
- ClinicalTrials.gov ID
- NCT04842578
- Acronym / sponsor ID
- thin cross- section of CT ZYP
- Conditions
- Segmentectomy, Video- Assisted Thoracoscopic Surgery, Three-dimensional-computed Tomography (3D-CT), Thin Cross- Section of CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of thin cross- section of CT | Experimental | Other: Cross- Section of CT Guided Anatomic SegmentectomyAnatomic Segmentectomy with the Guidance of Thin Cross- Section of CT |
| group of thin 3D simulation | Active comparator | Other: 3D simulation Guided Anatomic SegmentectomyAnatomic Segmentectomy with the Guidance of 3D simulation |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with single peripheral GGO lesion considered suspicious for malignancy;
- the lesion <2 cm in diameter and with at least one of the followings:
- pure adenocarcinoma in situ (AIS) histology;
- nodule has ≥50% ground-glass appearance on high resolution CT;
- radiologic surveillance conforms a long doubling time (≥400 days).
Key exclusion criteria (2 listed)
- patients with insufficient cardiopulmonary function;
- other contraindication for segmentectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross- Section of CT Guided Anatomic SegmentectomyThe anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT. | Other | group of thin cross- section of CT |
| 3D simulation Guided Anatomic SegmentectomyThe anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure. | Other | group of thin 3D simulation |
Primary outcome
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
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
operation time (minutes)
Time frame: from beginning to the end of surgery, up to 180 minutes
the duration of the operation time
confirmation time during surgery （number）
Time frame: Intraoperative
review time of the 3D reconstruction or the thin cross- section of CT during surgery
air leakage after surgery (days)
Time frame: within 7 days after surgery
the days of air leakage after surgery
the incidence of pneumonia （percentage）
Time frame: within 7 days after surgery
the incidence of pneumonia after surgery
the incidence of atelectasis （percentage）
Time frame: within 7 days after surgery
the incidence of atelectasis after surgery
Intraoperative bleeding (ml)
Time frame: Intraoperative
bleeding during anatomic segmentectomy, through the operation, an average of 100 ml
Chest tube duration (days)
Time frame: within 7 days after surgery
Chest tube duration after surgery
Postoperative hospital stay (days)
Time frame: within 7 days after surgery
hospital stay after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaogang Zhao study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross- Section of CT Guided Anatomic Segmentectomy and 3D simulation Guided Anatomic Segmentectomy in people with Segmentectomy and Video- Assisted Thoracoscopic Surgery, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.