Lung NeoplasmsNCT07686549
Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection
A study testing Lung three-dimensional model and reconstruction-assisted preoperative consultation and Usual preoperative consultation in people with Lung Neoplasms and Thoracoscopic Lung Resection, run by Tongji Hospital.
Trial summary
This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Thoracoscopic Lung Resection, Shared Decision Making
- What is being tested?
- Lung three-dimensional model and reconstruction-assisted preoperative consultation and Usual preoperative consultation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy.
- The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon.
- Clinically stable and able to participate in preoperative consultation.
- Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff.
- Able and willing to provide written informed consent. -
Who cannot join
- Emergency surgery.
- Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment.
- Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading.
- Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion.
- Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication.
- Any other condition judged by the investigators to make the patient unsuitable for this study.
- -
About this study
Official title: Patient-Specific Three-Dimensional Thoracic Anatomical Model-Assisted Preoperative Consultation to Improve Shared Decision-Making in Patients Undergoing Thoracoscopic Lung Resection: A Single-Center Cluster Randomized Controlled Trial
This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection.
Six attending thoracic surgeons will be randomized to provide either three-dimensional model-assisted consultation or usual preoperative consultation. Patients in the intervention group will receive consultation supported by a generic lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from routine preoperative imaging. Patients in the control group will receive usual preoperative consultation according to current clinical practice.
The primary outcome is patient-perceived shared decision-making measured immediately after consultation using the 9-item Shared Decision-Making Questionnaire. Secondary outcomes include anxiety, disease- and surgery-related knowledge, communication satisfaction, health-related quality of life, decision regret, consultation duration, and postoperative outcomes within 30 days.
- Conditions
- Lung Neoplasms, Thoracoscopic Lung Resection, Shared Decision Making, Preoperative Counseling
- Being tested
- Lung three-dimensional model and reconstruction-assisted preoperative consultation, Usual preoperative consultation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung three-dimensional model and reconstruction-assisted preoperative consultationBehavioural
In the intervention arm, surgeons will use a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data to support preoperative consultation. The reconstruction will be generated from clinically indicated routine imaging examinations and will be displayed dynamically on a physician workstation. The surgeon will use these tools to explain the lesion location, involved lobe or segment, planned resection extent, bronchovascular anatomy, lymph node assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study.
Usual preoperative consultationBehavioural
Patients in the control arm will receive usual preoperative consultation according to current clinical practice. Usual consultation may include oral explanation, review of routine computed tomography images, surgical diagrams, printed materials, and discussion of diagnosis, treatment options, risks, and expected recovery. The lung three-dimensional model and dynamic three-dimensional reconstruction display will not be used.
| Study group | Role | What they receive |
|---|---|---|
| Lung 3D model and reconstruction-assisted consultation | Experimental | Patients will receive usual preoperative consultation supplemented by a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from clinically indicated routine imaging examinations. Receives: Behavioral: Lung three-dimensional model and reconstruction-assisted preoperative consultation |
| Usual preoperative consultation | Active comparator | Patients will receive usual preoperative consultation according to current departmental practice without structured use of the lung three-dimensional model or workstation-based dynamic three-dimensional reconstruction display. Receives: Behavioral: Usual preoperative consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
Measured: Immediately after consultation
Secondary outcomes (6)
State anxiety score measured by the 6-item State-Trait Anxiety Inventory
Measured: Baseline before consultation, immediately after consultation, and 7 days after surgery
Disease- and surgery-related knowledge score
Measured: Baseline before consultation and immediately after consultation
Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form
Measured: 7 days after surgery
Health-related quality of life measured by EQ-5D-5L
Measured: Baseline, 7 days after surgery, and 30 days after surgery
Decision regret score measured by the Decision Regret Scale
Measured: 7 days after surgery and 30 days after surgery
Consultation duration
Measured: During the preoperative consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686549
- Sponsor's protocol ID
- TJ-IRB202605035
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Specific Three-Dimensional Thoracic Anatomical Model-Assisted Preoperative Consultation to Improve Shared Decision-Making in Patients Undergoing Thoracoscopic Lung Resection: A Single-Center Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07686549
- Acronym / sponsor ID
- TJ-IRB202605035
- Conditions
- Lung Neoplasms, Thoracoscopic Lung Resection, Shared Decision Making, Preoperative Counseling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection.
Six attending thoracic surgeons will be randomized to provide either three-dimensional model-assisted consultation or usual preoperative consultation. Patients in the intervention group will receive consultation supported by a generic lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from routine preoperative imaging. Patients in the control group will receive usual preoperative consultation according to current clinical practice.
The primary outcome is patient-perceived shared decision-making measured immediately after consultation using the 9-item Shared Decision-Making Questionnaire. Secondary outcomes include anxiety, disease- and surgery-related knowledge, communication satisfaction, health-related quality of life, decision regret, consultation duration, and postoperative outcomes within 30 days.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung 3D model and reconstruction-assisted consultation | Experimental | Behavioral: Lung three-dimensional model and reconstruction-assisted preoperative consultationPatients will receive usual preoperative consultation supplemented by a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from clinically indicated routine imaging examinations. |
| Usual preoperative consultation | Active comparator | Behavioral: Usual preoperative consultationPatients will receive usual preoperative consultation according to current departmental practice without structured use of the lung three-dimensional model or workstation-based dynamic three-dimensional reconstruction display. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy.
- The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon.
- Clinically stable and able to participate in preoperative consultation.
- Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff.
Key exclusion criteria (7 listed)
- Emergency surgery.
- Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment.
- Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading.
- Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion.
- Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication.
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 |
|---|---|---|
| Lung three-dimensional model and reconstruction-assisted preoperative consultationIn the intervention arm, surgeons will use a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data to support preoperative consultation. The reconstruction will be generated from clinically indicated routine imaging examinations and will be displayed dynamically on a physician workstation. The surgeon will use these tools to explain the lesion location, involved lobe or segment, planned resection extent, bronchovascular anatomy, lymph node assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study. | Behavioural | Lung 3D model and reconstruction-assisted consultation |
| Usual preoperative consultationPatients in the control arm will receive usual preoperative consultation according to current clinical practice. Usual consultation may include oral explanation, review of routine computed tomography images, surgical diagrams, printed materials, and discussion of diagnosis, treatment options, risks, and expected recovery. The lung three-dimensional model and dynamic three-dimensional reconstruction display will not be used. | Behavioural | Usual preoperative consultation |
Primary outcome
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
Time frame: Immediately after consultation
6 secondary outcomes
State anxiety score measured by the 6-item State-Trait Anxiety Inventory
Time frame: Baseline before consultation, immediately after consultation, and 7 days after surgery
Disease- and surgery-related knowledge score
Time frame: Baseline before consultation and immediately after consultation
Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form
Time frame: 7 days after surgery
Health-related quality of life measured by EQ-5D-5L
Time frame: Baseline, 7 days after surgery, and 30 days after surgery
Decision regret score measured by the Decision Regret Scale
Time frame: 7 days after surgery and 30 days after surgery
Consultation duration
Time frame: During the preoperative consultation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lung three-dimensional model and reconstruction-assisted preoperative consultation and Usual preoperative consultation in people with Lung Neoplasms and Thoracoscopic Lung Resection, run by Tongji Hospital.
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 7 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire (time frame: Immediately after consultation). 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 7 Jul 2026.