Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Neoplasms; Shared Decision Making; Thoracoscopic Lung Resection; Preoperative Counseling
• Intervention / Treatment: Behavioral: Lung three-dimensional model and reconstruction-assisted preoperative consultation; Behavioral: Usual preoperative consultation

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 18 years or older.
2. Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy.
3. The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon.
4. Clinically stable and able to participate in preoperative consultation.
5. Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff.
6. Able and willing to provide written informed consent. -

Exclusion Criteria:

1. Emergency surgery.
2. Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment.
3. Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading.
4. Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion.
5. Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication.

6. Any other condition judged by the investigators to make the patient unsuitable for this study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung 3D model and reconstruction-assisted consultation; 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.	Behavioral: Lung three-dimensional model and reconstruction-assisted preoperative consultation; 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.
Active Comparator: Usual preoperative consultation; 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.	Behavioral: Usual preoperative consultation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire	Immediately after consultation

Secondary Outcome Measures

Outcome Measure	Time Frame
State anxiety score measured by the 6-item State-Trait Anxiety Inventory	Baseline before consultation, immediately after consultation, and 7 days after surgery
Disease- and surgery-related knowledge score	Baseline before consultation and immediately after consultation
Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form	7 days after surgery
Health-related quality of life measured by EQ-5D-5L	Baseline, 7 days after surgery, and 30 days after surgery
Decision regret score measured by the Decision Regret Scale	7 days after surgery and 30 days after surgery
Consultation duration	During the preoperative consultation

Other Outcome Measures

Outcome Measure	Time Frame
Observed shared decision-making during optional audio-recorded consultations measured by Observer OPTION-5	During the index preoperative consultation
Number and type of patient and family questions during optional audio-recorded consultations	During the index preoperative consultation
Adherence to the core consultation checklist during optional audio-recorded consultations	During the index preoperative consultation
Postoperative complications within 30 days	Within 30 days after surgery
Postoperative length of hospital stay	Perioperative
Unplanned readmission within 30 days	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: TJ-IRB202605035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No