Navigational Bronchoscopy Versus CT-Guided Radioisotope Markings: A Randomized Controlled Trial of Preoperative Localization in Uniportal VATS Wedge Resections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time of Surgery
研究概览
简要总结
This clinical trial aims to determine whether navigational bronchoscopic or CT-guided marking is more effective for localizing small pulmonary nodules in minimally invasive thoracic surgery. It will also assess the safety of both methods. The main questions to answer are:
- Which of the two methods enables the surgeon to locate the lesion more quickly during surgery?
- Does using the newer navigational bronchoscopic method reduce the number of insufficient resections, meaning that the lesions were not completely removed, thus affecting the surgical margin?
Researchers will compare navigational bronchoscopic ICG (visible green dye on the screen) marking to CT-guided transthoracic radioisotope targeting (a substance that emits radiation and can be detected with a specific device) to evaluate whether bronchoscopy with ICG dye is equally effective or even superior without exposing patients to radiation.
Participants will:
- Undergo an additional procedure before surgery to make the lesions detectable (Preoperative marking).
- Proceed to surgery in accordance with standard practices.
- Visit the clinic once after three weeks for follow-up checks and tests.
- Grant access to the pathological results for researchers to analyze and store data.
详细描述
Two different preoperative markings have proven invaluable for excising smaller pulmonary lesions. Electromagnetic navigation bronchoscopy (NAVIB) provides a more minimally invasive approach, particularly advantageous for centrally located lesions or patients with a higher risk of pneumothorax. CT-guided transthoracic radioisotope marking (CTI), on the other hand, is highly accurate for peripheral lesions and allows real-time confirmation of the marker's placement. However, it remains unclear whether one technique is superior under specific surgical conditions.
This study is a single-center, 1:1 randomized controlled trial evaluating whether NAVIB using indocyanine green dye or CTI with macroalbumin-aggregated technetium-99 99 is more effective for localization during uniportal wedge resections of lung nodules ranging from 10 to 30 mm. The primary endpoint is the duration of the surgical procedure, with secondary endpoints including complication rates, surgical margin, and surgeon satisfaction assessed through specific questionnaires.
The investigators have completed a running-up phase of the study and conducted a retrospective analysis of the data since 2022. They plan to randomize 81 patients, believing that ICG dye marking will facilitate the surgery, reduce operating time, and enhance the visibility of lung nodules. Based on preliminary data, the investigators expect an average time reduction of 10 minutes, with a standard deviation of 15 minutes. Using a power of 0.8 with a 0.05 alpha level, they determined that 74 patients are needed for the primary outcome. With an anticipated loss to follow-up or exclusions of 10%, the final target has been extended to 81 patients. Recruitment will begin once the trial has been registered internationally.
The results will be analyzed using a two-sided t-test for continuous variables (e.g., length of surgeries) and a chi-squared test for categorical variables when appropriate (e.g., complications and surgical margin positivity). In the questionnaire, the investigators will utilize a scale from 1 (not helpful) to 4 (very helpful) to assess surgeons' subjective preferences.
These results could help evaluate the safety and efficiency of both techniques, which is essential in choosing between the available marking methods and could aid in establishing new protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization occurs before surgery and is stratified by the operating surgeon using a random permuted block design with block sizes of 2 and 4. This method ensures balance among the surgeons and prevents long runs of the same group. The pathologist responsible for assessing the resections will not have access to group assignments. In this trial, only the patients, the pathologist, and the statisticians will be blinded. Due to the nature of the techniques, it is not possible to blind the surgeons and operative staff since both methods require different equipment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In this study, patients with lung nodules between 10 and 30 mm (under clinical IC or lower stage if it was a case of NSCLC) who are fit for surgery will be enrolled. The investigators will collect epidemiological data, including age, race, gender, Charlson Comorbidity Index, smoking history, medications taken, previous surgeries, significant diseases, BMI, and detailed parameters of the radiological size of the tumor preoperatively. Within two months before surgery, the investigators will conduct a contrast-enhanced chest CT, which will include the upper abdomen and lung function tests (FVC, FEV1, DLCO). Patients who had previous thoracic surgery, are under 18 or over 85 years of age, or have FVC or FEV1 less than 60% will be excluded. Any patient unsuitable for the complete preoperative diagnostic procedure will also be excluded (for example, where contrast material is contraindicated in chronic kidney failure). Pathological parameters of the lesion will be evaluated within four weeks after surgery. Imaging will be conducted at least during the one-month follow-up to monitor complications.
- •Inclusion Criteria:
- •Aged from 18 to 85
- •1-3 cm lung nodules
- •planned procedure VATS uniportal diagnostic wedge
排除标准
- •Previous thoracic surgery
- •CCI greater than 12
- •Long-term steroid treatment
研究组 & 干预措施
Navigational bronchoscopy
For electromagnetic navigational bronchoscopic markings, the investigators use the Medtronic SuperDimension system. The process starts with a planning phase in which a thin-sliced (0.8-1.25 mm) CT scan is uploaded into the software, segmenting the airways and reconstructing the bronchial tree, allowing us to plan the best route to the lesion. During the procedure, the patient lies supine on a board emitting a low-frequency electromagnetic field. An Olympus™ bronchoscope with an extended working channel (EWC) is employed, and a locatable guide is placed into the airway. Registration matches the patient's airway to the virtual bronchial tree. Once the investigators reach the lesion, they secure the EWC and administer 2 ml of ICG 5 mg/ml solution through a 21G TBNA needle to mark it. After removing the bronchoscope, selective intubation is performed. The investigators proceed to surgery using a near-infrared Olympus optic.
干预措施: Preoperative marking (Procedure)
CT guided markings
Localization of lung lesions before surgery using CT-guided transthoracic 99mTc isotope placement (CTI) follows a specific protocol. The investigators prepare 99mTc-MAA using macroalbumin and Tc-99m, targeting 220-240 MBq in 3 ml and administering 14-16 MBq (0.2 ml) while considering the remaining syringe volume. An interventional radiologist performs the marking on the same day as the surgery, ideally in the morning. Patients are positioned for easy access to the lesion. Native CT images confirm nodule localization. Local anesthetic, typically 20 ml of 10 mg/ml Lidocaine, is injected after confirming the entry point with a 22G needle. The isotope is injected through a 15 cm 22G applicator. A final CT scan checks for complications before transferring the patient for surgery. In the operating theater, the Europrobe detects the nodule marked prior to wedge resection. Isotope marking occurs two hours before surgery, with repetition required if more than six to eight hours elapse.
干预措施: Preoperative marking (Procedure)
结局指标
主要结局
Time of Surgery
时间窗: From the initiation of anesthesia to the completion of the surgery
Time needed for completion of wedge resection in minutes
Surgical Satisfaction Survey
时间窗: From the completion of surgery within 24 hours
The investigators assess the surgeons' experiences after the surgery using a questionnaire consisting of 9 questions, with answers on a scale from 1 to 4, where 1 is a poor outcome, 2 is neutral, 3 is acceptable, and 4 is a favorable outcome. Questions: 1. How difficult was locating the lesion during the surgery? 2. How challenging was the location of the lesion during the surgery? 3. How challenging was taking out the lesion and positioning the stapler? 4. How satisfied is the surgeon with the speed of the operation compared to the planned surgical time? 5. After removal, did the resected specimen contain the lesion? 6. Were there any issues with the marking? (e.g., gamma camera malfunction) 7. How effective was the preoperative marking in helping to locate the lesion? 8. How accurately did the marking correspond to the actual location of the lesion? 9. How satisfied was the surgeon with the quality of the marking overall?
次要结局
- Hospital stay (days)(From the surgery up to 4 weeks)
- Conversion rates(During surgery)
- The length of surgical margins in mm(Within 3 weeks after surgery)
- Tube duration days(From the surgery up to 4 weeks)
- Complication rates(From the surgery up to 4 weeks)
- The frequency of surgical margins greater than or equal to 10 mm(From the surgery in 3 weeks)
研究者
Dr. Csaba Márton
Clinical surgeon
Semmelweis University