The Comparison of Navigational Bronchoscopic and CT-Guided Preoperative Markings in Minimally Invasive Thoracic Surgery

NCT06957600 | Completed DMC

• 2 other identifiers: BMEÜ/2368-1/2022/EKU2025-522130-31-00
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

VATS; Lung; ICG (Indocyanine Green)

Keywords

VATS; ICG; navigational bronchoscopy; CT-guided radioisotope targeting; surgical margin; questionnaire; time

Outcome Measures

Primary Outcomes (2)

• Time of Surgery

  Time needed for completion of wedge resection in minutes

  From the initiation of anesthesia to the completion of the surgery

• Surgical Satisfaction Survey

  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?

  From the completion of surgery within 24 hours

Secondary Outcomes (6)

• Complication rates

  From the surgery up to 4 weeks

• Hospital stay (days)

  From the surgery up to 4 weeks

• Tube duration days

  From the surgery up to 4 weeks

• Conversion rates

  During surgery

• The length of surgical margins in mm

  Within 3 weeks after surgery

Study Arms (2)

Navigational bronchoscopy

ACTIVE COMPARATOR

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.

Procedure: Preoperative marking

CT guided markings

ACTIVE COMPARATOR

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.

Procedure: Preoperative marking

Interventions

Preoperative marking PROCEDURE

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.

CT guided markings; Navigational bronchoscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 85
• cm lung nodules
• planned procedure VATS uniportal diagnostic wedge

You may not qualify if:

• Previous thoracic surgery
• CCI greater than 12
• Long-term steroid treatment

Sponsors & Collaborators

• Semmelweis University: lead
• National Institute of Oncology, Hungary: collaborator

Study Sites (1)

Semmelweis University- National Institute of Oncology Department of Thoracic Surgery

Budapest, Budapest, 1122, Hungary

Location

Related Publications (12)

• Bawaadam H, Benn BS, Colwell EM, Oka T, Krishna G. Lung Nodule Marking With ICG Dye-Soaked Coil Facilitates Localization and Delayed Surgical Resection. Ann Thorac Surg Short Rep. 2023 Feb 27;1(2):221-225. doi: 10.1016/j.atssr.2023.02.010. eCollection 2023 Jun.

  PMID: 39790308 BACKGROUND

• Yanagiya M, Kawahara T, Ueda K, Yoshida D, Yamaguchi H, Sato M. A meta-analysis of preoperative bronchoscopic marking for pulmonary nodules. Eur J Cardiothorac Surg. 2020 Jul 1;58(1):40-50. doi: 10.1093/ejcts/ezaa050.

  PMID: 32563193 BACKGROUND

• Lee MO, Jin SY, Lee SK, Hwang S, Kim TG, Song YG. Video-assisted thoracoscopic surgical wedge resection using multiplanar computed tomography reconstruction-fluoroscopy after CT guided microcoil localization. Thorac Cancer. 2021 Jun;12(11):1721-1725. doi: 10.1111/1759-7714.13968. Epub 2021 May 4.

  PMID: 33943015 BACKGROUND

• Farkas A, Kocsis A, Andi J, Sinkovics I, Agocs L, Meszaros L, Torok K, Bogyo L, Radecky P, Ghimessy A, Gieszer B, Lang G, Renyi-Vamos F. [Minimally invasive resection of nonpalpable pulmonary nodules after wire- and isotope-guided localization]. Orv Hetil. 2018 Aug;159(34):1399-1404. doi: 10.1556/650.2018.31148. Hungarian.

  PMID: 30122061 BACKGROUND

• Nelson DB, Tayob N, Mitchell KG, Correa AM, Hofstetter WL, Sepesi B, Walsh GL, Vaporciyan AA, Swisher SG, Antonoff MB, Roth JA, Rice DC, Vauthey JN, Mehran RJ. Surgical margins and risk of local recurrence after wedge resection of colorectal pulmonary metastases. J Thorac Cardiovasc Surg. 2019 Apr;157(4):1648-1655. doi: 10.1016/j.jtcvs.2018.10.156. Epub 2018 Nov 26.

  PMID: 30635188 BACKGROUND

• Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.

  PMID: 16608948 BACKGROUND

• Krauel L, Pasten A, Gorostegui M, Mane S, Martin Gimenez MP, Coronas M, Carrasco Torrents R, Mora J. Use of Radioguided Surgery for Small and Difficult-to-Locate Relapsed MIBG (+) High-Risk Neuroblastoma Lesions. Cancers (Basel). 2024 Sep 30;16(19):3348. doi: 10.3390/cancers16193348.

  PMID: 39409967 BACKGROUND

• Galetta D, Rampinelli C, Funicelli L, Casiraghi M, Grana C, Bellomi M, Spaggiari L. Computed Tomography-Guided Percutaneous Radiotracer Localization and Resection of Indistinct/Small Pulmonary Lesions. Ann Thorac Surg. 2019 Sep;108(3):852-858. doi: 10.1016/j.athoracsur.2019.03.102. Epub 2019 May 7.

  PMID: 31075251 BACKGROUND

• Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.

  PMID: 21256276 BACKGROUND

• Park CH, Han K, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon W, Kim TH, Choi BW. Comparative Effectiveness and Safety of Preoperative Lung Localization for Pulmonary Nodules: A Systematic Review and Meta-analysis. Chest. 2017 Feb;151(2):316-328. doi: 10.1016/j.chest.2016.09.017. Epub 2016 Oct 4.

  PMID: 27717643 BACKGROUND

• Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.

  PMID: 23649456 BACKGROUND

• Keating J, Singhal S. Novel Methods of Intraoperative Localization and Margin Assessment of Pulmonary Nodules. Semin Thorac Cardiovasc Surg. 2016 Spring;28(1):127-36. doi: 10.1053/j.semtcvs.2016.01.006. Epub 2016 Feb 4.

  PMID: 27568150 BACKGROUND

MeSH Terms

Conditions

Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Áron Ghimessy, MD. PhD. MSc

  Semmelweis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical surgeon

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: June 1, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)