Clinical trial · Interventional
Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization
Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization: A Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small and/or Deep Lung Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid Dyna-CT guided localization | Procedure | — | UNRESOLVED |
| Preoperative CT scan-guided localization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Preoperative CT scan-guided localization
- description
- 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.
- interventionNames
- Procedure: Preoperative CT scan-guided localization
- type
- EXPERIMENTAL
- label
- Hybrid Dyna-CT guided localization
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (21)
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