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

NCT06957600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-09-05

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • National Institute of Oncology, Hungary

    collaborator OTHER

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Áron Ghimessy, MD. PhD. MSc · Semmelweis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-08-26
Completion
2025-08-26

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06957600 on ClinicalTrials.gov