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

August 30, 2025 updated by: Dr. Csaba Márton, Semmelweis University

Navigational Bronchoscopy Versus CT-Guided Radioisotope Markings: A Randomized Controlled Trial of Preoperative Localization in Uniportal VATS Wedge Resections

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1122
        • Semmelweis University- National Institute of Oncology Department of Thoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Preoperative 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.
Active Comparator: 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.
Procedure: Preoperative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Surgery
Time Frame: From the initiation of anesthesia to the completion of the surgery
Time needed for completion of wedge resection in minutes
From the initiation of anesthesia to the completion of the surgery
Surgical Satisfaction Survey
Time Frame: 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?
From the completion of surgery within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rates
Time Frame: During surgery
Conversion is defined as an anterolateral thoracotomy that is large enough to allow the surgeon's hand access to the thoracic cavity.
During surgery
Complication rates
Time Frame: 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.
From the surgery up to 4 weeks
Hospital stay (days)
Time Frame: From the surgery up to 4 weeks
The number of days between surgery and discharge
From the surgery up to 4 weeks
Tube duration days
Time Frame: From the surgery up to 4 weeks
The number of days after which the investigators can remove the thoracic drain.
From the surgery up to 4 weeks
The length of surgical margins in mm
Time Frame: 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.
Within 3 weeks after surgery
The frequency of surgical margins greater than or equal to 10 mm
Time Frame: 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.
From the surgery in 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

National Institute of Oncology, Hungary

Investigators

  • Study Director: Áron Ghimessy, MD. PhD. MSc, Semmelweis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

August 26, 2025

Study Completion (Actual)

August 26, 2025

Study Registration Dates

First Submitted

April 26, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMEÜ/2368-1/2022/EKU
  • 2025-522130-31-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators take data control seriously. In the investigator's initial approach, the investigator does not share patients' confidential data with any third party. The primary patient consent form was created with this principle in mind. Once the study is completed and demonstrates potential benefits for scientific purposes, the investigator may consider sharing the data if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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