Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395964
Recruitment Status : Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Studies have shown decreased 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 be difficult by VATS, and a more significant resection or conversion to thoracotomy is occasionally needed to ensure complete 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 and described to mark lung nodules for easier identification of small nodules and help guide resection during VATS. However, there are certain concerns. First, there are the difficult logistics in minimizing the time between the localization procedure and the subsequent surgery. Second, there is concern for patient safety, in particular pneumothorax, during transfer to and from the ward to the radiology department and in the frequent delays and waiting in reception areas prior to transfer to operating heaters. 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 hybrid operating room environment.

In the current study, the investigators will perform intraoperative lung tumor localization in CGMH hybrid operation room (Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. Through a randomized study design, the advantages, disadvantages, and important considerations of this combined approach will be compared with traditional preoperative CT scan guided localization protocol.


Condition or disease Intervention/treatment Phase
Small and/or Deep Lung Tumor Procedure: Hybrid Dyna-CT guided localization Procedure: Preoperative CT scan-guided localization Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization: A Randomized Study
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Preoperative CT scan-guided localization
Preoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo GIA II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy.
Procedure: Preoperative CT scan-guided localization
Preoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo GIA II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy.

Experimental: Hybrid Dyna-CT guided localization
Patients will be brought into the Hybrid OR, and placed in the lateral decubitus position. A C-arm CT scan of the pre-determined field of view that included the nodule position will be acquired during an end-inspiratory hold maneuver using a 5 sec scan protocol with 0.36mGy/projection and 248 projections acquired over 200°. The radiologist reviewed the C-arm CT scan to localize the nodule and plan trajectories for percutaneous hook-wire placement using Syngo iGuide needle guidance software. The planned needle pathways will be integrated into the C-arm fluoroscopic imaging system, which provided laser crossbar and guidance markers on fluoroscopy images to direct the needle pathway for hook wire placement.
Procedure: Hybrid Dyna-CT guided localization
We will perform intraoperative lung tumor localization in CGMH hybrid operation room(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep.




Primary Outcome Measures :
  1. Procedure time [ Time Frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year. ]
    Recording the time of localization procedure, including needle puncture time.


Secondary Outcome Measures :
  1. Complications [ Time Frame: Beginning from localization until operation, through study completion, an average of 2 year. ]
    pneumothorax and hemorrhage

  2. Radiation dose [ Time Frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year. ]
    Effective dose estimates were performed using thermoluminescent dosimeters (TLD).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lesions <1 cm or those at a distance more than 1.5cm from the lung periphery.

Exclusion Criteria:

  • confirmed as a malignancy
  • Age <18
  • serious pulmonary heart disease
  • more than one tumors needed localization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395964


Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yin-Kai Chao Chang Gung Memorial Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03395964    
Other Study ID Numbers: CGMH-IRB-201600671A3
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases