Comparing two surgical techniques for lung nodules

Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study

This study tests whether a new way of performing lung surgery can be safer and lead to better results for patients with lung nodules compared to the standard method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06202053 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of a modified periareolar incision compared to conventional uniportal video-assisted thoracic surgery for patients undergoing surgery for pulmonary nodules. The modified approach aims to minimize damage to the mammary gland by creating a subcutaneous tunnel, potentially leading to better cosmetic outcomes and fewer complications. The study will involve a randomized controlled design to assess outcomes in patients who meet specific eligibility criteria for thoracoscopic surgery. The goal is to improve surgical techniques in minimally invasive thoracic surgery.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18-75 who are eligible for thoracoscopic surgery and have good movement of the areola.

Not a fit: Patients with a history of previous breast surgery or those requiring conversion to thoracotomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and enhanced postoperative quality of life for patients.

How similar studies have performed: While the modified periareolar approach is less commonly reported, similar minimally invasive techniques have shown promise in improving surgical outcomes.

Eligibility criteria

Inclusion criteria:

1. Male or female patients aged 18-75 years
2. Good degree of movement of the areola (being able to move to the anterior axillary line)
3. Meeting the criteria for thoracoscopic surgery, including lobectomy (expected absence of adhesions, well-developed interlobar fissure) and sublobectomy (including segmentectomy and wedge resection)
4. No evidence of advanced lung cancer on preoperative evaluation
5. No history of chemotherapy, immunotherapy, or radiotherapy
6. ECOG performance status 0-1;
7. Patients and their families agreed to participate in this study and signed a written informed consent form.

Exclusion criteria:

1. Patients had previously undergone pneumonectomy or preoperative chemotherapy and/or radiotherapy
2. Previous breast surgery
3. Risk of conversion to thoracotomy or changing the incision during the operation
4. Poor preoperative lung function
5. Presence of other cancers or other advanced diseases
6. Preoperative pulmonary infection or uncontrolled acute pulmonary disease or acute exacerbation of chronic obstructive pulmonary disease
7. Severe hypertension (resting systolic/diastolic blood pressure of \>180/100 mmHg), intracranial mass, or intracranial hypertension
8. Recent brain injury, cerebral infarction, or cerebral hemorrhage
9. Hyperthyroidism
10. Previous history of angina pectoris, myocardial infarction, or heart failure
11. History of thoracoscopic resection of mediastinal and pleura tumors
12. Central nervous system disease; mental or neurological diseases, cognitive or language dysfunction due to which the patient was unable to cooperate with the follow-up
13. Pregnant or lactating women

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Bin Zheng, MD

Conditions: Surgical Incision, Minimally Invasive Surgery