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

NCT07686549 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202605035
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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. 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; Preoperative Counseling; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire

  Immediately after consultation

Secondary Outcomes (6)

• 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

Other Outcomes (6)

• 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

Study Arms (2)

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.

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.

Behavioral: Usual preoperative consultation

Interventions

Lung three-dimensional model and reconstruction-assisted preoperative consultation BEHAVIORAL

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.

Lung 3D model and reconstruction-assisted consultation

Usual preoperative consultation BEHAVIORAL

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.

Usual preoperative consultation

Eligibility Criteria

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

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the visible nature of the communication intervention, surgeons and participants cannot be blinded. Research staff responsible for questionnaire administration, clinical outcome extraction, and statistical analysis will be blinded to group allocation whenever feasible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06