Clinical trial NCT04182152: Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
Official title: Bronchoscopic ICG Injection vs Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in Video-assisted Thoracoscopic Sublobar Resection: A Prospective and Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Electromagnetic navigation bronchoscopy (ENB)
localization
Lung cancer
Video-associated thoracic surgery
Indocyanine green (ICG)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.

Detailed description: This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old;
* With lung nodule diameter ≤2cm and distance from pleura ≥1cm, and VATS sublobar resection is arranged;
* Located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed.

Exclusion Criteria:

* Cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy;
* More than one pulmonary nodule requires preoperative localization;
* Subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions;
* The nodule puncture path has bony structure block;
* Others conditions that the investigator considers not appropriate for this trial.

Primary outcomes:
measure: Success rate of the localization procedure
timeFrame: On the 1 day of localization operation
measure: Success rate of the effective localization
timeFrame: On the 1 day of VATS operation
measure: Success rate of VATS sublobar resection
timeFrame: On the 1 day of VATS completion
Secondary outcomes:
measure: Safety endpoint
timeFrame: On the 1 day of VATS operation
measure: Localization time
timeFrame: On the 1 day of localization operation
measure: Operation time of VATS sublobar resection
timeFrame: On the 1 day of VATS completion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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