CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
localizationprocedure
Likely dose
Not stated in record
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Search/NCT04974632
NCT04974632N/ACompleted

Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial

Chang Gung Memorial Hospital·interventional·Posted Jul 23, 2021·Updated Feb 26, 2025

In Brief

A clinical study evaluating localization for Lung Tumor and Thoracoscopic Surgery. Completed, enrolled 41 participants across 1 site.

Detailed Summary

It is well known that video-assisted thoracoscopic surgery (VATS) is preferred to open surgery for lung resection because of the smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization and much decreased local tenderness. Studies have shown less operative and post-operative morbidity with decreased operative times. However, for small nodules (i.e. lesions \<1 cm or those at a distance more than 1.5cm from the lung periphery), adequate identification of the target nodule has been being difficult by VATS with necessity of more significant resection or thoracotomy conversion to ensure complete tumor resection. In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed. It has been proved to be much easier to mark lung nodules and help guide resection during VATS. However, there are certain concerns. First, it is difficult to minimize the time between the localization procedure and the subsequent surgery in reality. Second, there is concern for patient safety, in particular pneumothorax or hemothorax, during transferred to and from the ward to the radiology suit and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hook wire dislodgement. Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same operating room environment. We performed single-step localization and removal of small pulmonary nodules in the hybrid OR equipped with floor-mounted C-arm cone-beam computed tomography (CBCT) in the previous study. However, it costed a lot of money and every localization could only be performed in the hybrid OR. Mobile 3D C-arm CT is another form of CBCT. It depicts soft tissues with high contrast but also offer a more affordable solution with relative low cost. In this case series, we will investigate the use of a mobile 3D C-arm CT for single-step localization and removal of small pulmonary nodules.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 23, 2021
Enrollment StartJul 1, 2021
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.9 years ago

Interventions

localizationprocedure

small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)