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

NCT04974632 | Completed

• 1 other identifier: 202100442A3
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Tumor; Thoracoscopic Surgery

Keywords

Lung tumor; mobile 3D C-arm computed tomography(CT); Video-assisted thoracoscopic surgery (VATS)

Outcome Measures

Primary Outcomes (2)

• Procedure time

  Recording the time of localization procedure, including needle puncture time.

  from initiation of the procedure time (first time CT scanning) to the end (localization complete).

• success rate of localization

  Recording the result of localization (success or not), the failure reason, and the deviation distance

  from initiation of localization to completion of surgery

Secondary Outcomes (2)

• Radiation dose

  from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 1 year.

• Complication rate

  from initiation of localization to completion of surgery

Study Arms (1)

localization

OTHER

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

Procedure: localization

Interventions

localization PROCEDURE

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

localization

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<1 cm, those at a distance more than 1.5 cm from the lung periphery, or ground-glass opacity (GGO) lung lesion.

You may not qualify if:

• Age \<20 serious pulmonary heart disease more than one tumors needed localization

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yin-Kai Chao, MD, Ph D

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 23, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 26, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)