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

NCT03395964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

  • Small and/or Deep Lung Tumor

Interventions

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.

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yin-Kai Chao · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2019-12-30
Completion
2020-05-31

Countries

  • Taiwan

Study Locations

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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 NCT03395964 on ClinicalTrials.gov