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

Primary Purpose

Lung Tumor, Thoracoscopic Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
localization
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Tumor focused on measuring Lung tumor, mobile 3D C-arm computed tomography(CT), Video-assisted thoracoscopic surgery (VATS)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

localization

Arm Description

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

Outcomes

Primary Outcome Measures

Procedure time
Recording the time of localization procedure, including needle puncture time.
success rate of localization
Recording the result of localization (success or not), the failure reason, and the deviation distance

Secondary Outcome Measures

Radiation dose
Effective dose estimates were performed using thermoluminescent dosimeters (TLD).
Complication rate
Recording the rate of common complications, such as pneumothorax, hemothorax.

Full Information

First Posted
July 21, 2021
Last Updated
July 23, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04974632
Brief Title
Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial
Official Title
Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Pre-operative CT scans will be used for localization planning. The images will be reviewed by our team to determine optimal placement of wires or indocyanine green. After induction of general anesthesia and insertion of a double-lumen tube, the patient will be placed in either supine, prone or lateral decubitus position. Under end-inspiratory breath-hold, an initial 30 second rotary scan for surgical planning will be obtained. The puncture path will be planned to be as short as possible while avoiding transfissural punctures or being oriented towards major vascular structure. The skin entry site for the planned needle puncture route will then identified under the guidance of the referential metallic marker. An 18-gauze marker needle will be gradually advanced under CT-guidance until it reached the target lesion. A total of 0.3 ml ICG dye(for superficial lesion) or microcoil or hookwire(for deeper lesion) will then be used to localize the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Tumor, Thoracoscopic Surgery
Keywords
Lung tumor, mobile 3D C-arm computed tomography(CT), Video-assisted thoracoscopic surgery (VATS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
localization
Arm Type
Other
Arm Description
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Intervention Type
Procedure
Intervention Name(s)
localization
Intervention Description
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Primary Outcome Measure Information:
Title
Procedure time
Description
Recording the time of localization procedure, including needle puncture time.
Time Frame
from initiation of the procedure time (first time CT scanning) to the end (localization complete).
Title
success rate of localization
Description
Recording the result of localization (success or not), the failure reason, and the deviation distance
Time Frame
from initiation of localization to completion of surgery
Secondary Outcome Measure Information:
Title
Radiation dose
Description
Effective dose estimates were performed using thermoluminescent dosimeters (TLD).
Time Frame
from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 1 year.
Title
Complication rate
Description
Recording the rate of common complications, such as pneumothorax, hemothorax.
Time Frame
from initiation of localization to completion of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <1 cm, those at a distance more than 1.5 cm from the lung periphery, or ground-glass opacity (GGO) lung lesion. Exclusion Criteria: Age <20 serious pulmonary heart disease more than one tumors needed localization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-yueh Fang, MD
Phone
+88633281200
Ext
2118
Email
leomoon0723@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Kai Chao, MD, Ph D
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial

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