ICG (Indocyanine Green), Lung, VATS
Conditions
Keywords
VATS, ICG, navigational bronchoscopy, CT-guided radioisotope targeting, surgical margin, questionnaire, time
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPreoperative marking
Applying markings prior to uniport VATS wedge resections helps localize small, potentially early-stage lung tumors. After marking, the patients are positioned laterally and receive general anesthesia with single-lung ventilation. The investigators perform VATS wedge resection using uniportal techniques. The utility incision is made in the 5th intercostal space between the anterior and mid-axillary lines. Insufflation is not typically utilized. The lesion is localized, elevated, and confirmed by palpation. The investigators then staple around the lesion using the Endo GIA™ ultra universal stapler with an Articulating Reload featuring Tri-Staple™ Technology in 45 or 60 mm lengths, choosing purple or black loads based on parenchyma thickness. Finally, the investigators close the wound and place one chest drain in the thoracic cavity, set to active suction of 5-10 cm of water.
Sponsors
National Institute of Oncology, Hungary
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
This study is a prospective, single-center, randomized clinical trial comparing navigational bronchoscopic marking using indocyanine green dye (NAVIB) with CT-guided transthoracic marking using macroalbumin-aggregated Technetium-99 (CTI). The investigators plan to enroll patients with lung nodules measuring between 1 and 3 cm of unknown origin who are undergoing wedge resections. In the surgical approach, the investigators exclusively utilize video-assisted techniques (VATS), and all operations in this trial are intended to be performed using a uniportal approach. This study adheres to the guidelines outlined in the Helsinki Declaration and complies with all local regulatory requirements. All participants provided informed consent before undergoing surgery. The procedures will be conducted in the Department of Thoracic Surgery at the National Institute of Oncology in Budapest, which is affiliated with Semmelweis University. All surgeries will be performed by experienced surgeons.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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. Summary: Inclusion Criteria: * Aged from 18 to 85 * 1-3 cm lung nodules * planned procedure VATS uniportal diagnostic wedge
Exclusion criteria
* Previous thoracic surgery * CCI greater than 12 * Long-term steroid treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Surgery | From the initiation of anesthesia to the completion of the surgery | Time needed for completion of wedge resection in minutes |
| Surgical Satisfaction Survey | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tube duration days | From the surgery up to 4 weeks | The number of days after which the investigators can remove the thoracic drain. |
| Conversion rates | During surgery | Conversion is defined as an anterolateral thoracotomy that is large enough to allow the surgeon's hand access to the thoracic cavity. |
| Complication rates | From the surgery up to 4 weeks | Postoperative complications will be assessed based on the Ottawa Thoracic Morbidity & Mortality score system, a thoracic complication scoring system that follows the principles of the Clavien-Dindo score. |
| The frequency of surgical margins greater than or equal to 10 mm | From the surgery in 3 weeks | It is considered an incomplete or suboptimal resection if the resection margins do not exceed 10 mm; it is also correlated with a higher recurrence rate. That is why the investigators create a binary variable: yes if the length of the surgical margin is greater than or equal to 10 mm, and no if it is smaller than that. |
| The length of surgical margins in mm | Within 3 weeks after surgery | The smallest distance between the lesion and the stapling line, also referred to as the surgical margin, is measured by the pathologist and expressed in mm. |
| Hospital stay (days) | From the surgery up to 4 weeks | The number of days between surgery and discharge |
Countries
Hungary
Outcome results
None listed