Protocol for the VAL-MAP 2.0 trial: a multicentre, single-arm, phase III trial to evaluate the effectiveness of virtual-assisted lung mapping by bronchoscopic dye injection and microcoil implementation in patients with small pulmonary nodules in Japan

IntroductionTumour localisation is important for successful resection of lung nodules with optimal resection margins in sublobar resection. Virtual-assisted bronchoscopic localisation technique combined with dye marking and microcoil placement (VAL-MAP 2.0) is a minimally invasive, virtual-assisted, bronchoscopic technique that combines dye marking and microcoil implementation. As indwelling microcoils can provide information on the depth from the lung surface, they can be applied for deeply located small lung tumours that are barely identifiable by surface dye marking. This proposed study will examine the effectiveness of VAL-MAP 2.0 in patients with small pulmonary nodules.Methods and analysisThis is a multicentre, prospective, single-arm, clinical trial. A total of 65 patients will be registered to undergo VAL-MAP 2.0 followed by thoracoscopic surgery. The primary outcome is successful resection, defined as resection of the lesion with optimal resection margins. The goal of the study is the achievement of a successful resection rate of 80%.Ethics and disseminationThe study was approved by the Clinical Research Review Boards of the University of Tokyo (approval number 218 003SP) for all institutes, and the Technical Review Board for Advanced Medicine Category B of the Ministry of Health, Labour and Welfare. Results of the primary and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberjRCTs031180099

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Electromagnetic navigational bronchoscopy-directed dye marking for locating pulmonary nodules

Postgraduate Medical Journal ◽

10.1136/postgradmedj-2019-137083 ◽

2020 ◽

Vol 96 (1141) ◽

pp. 674-679

Author(s):

Long-long Wang ◽

Bi-fang He ◽

Jing-hua Cui ◽

Xing-lin Gao ◽

Ping-ping Chen ◽

...

Keyword(s):

Guide Wire ◽

Pulmonary Nodules ◽

Resection Margins ◽

Ct Guided ◽

Pleural Surface ◽

Visual Markers ◽

Registration Number ◽

The Mean ◽

Dye Marking ◽

Electromagnetic Navigational Bronchoscopy

BackgroundSmall peripheral pulmonary nodules, which are usually deep-seated with no visual markers on the pleural surface, are often difficult to locate during surgery. At present, CT-guided percutaneous techniques are used to locate pulmonary nodules, but this method has many limitations. Thus, we aimed to evaluate the accuracy and feasibility of electromagnetic navigational bronchoscopy (ENB) with pleural dye to locate small peripheral pulmonary nodules before video-associated thoracic surgery (VATS).MethodsThe ENB localisation procedure was performed under general anaesthesia in an operating room. Once the locatable guide wire, covered with a sheath, reached the ideal location, it was withdrawn and 0.2–1.0 mL of methylene blue/indocyanine green was injected through the guide sheath. Thereafter, 20–60 mL of air was instilled to disperse the dye to the pleura near the nodules. VATS was then performed immediately.ResultsStudy subjects included 25 patients with 28 nodules. The mean largest diameter of the pulmonary nodules was 11.8 mm (range, 6.0–24.0 mm), and the mean distance from the nearest pleural surface was 13.4 mm (range, 2.5–34.9 mm). After the ENB-guided localisation procedure was completed, the dye was visualised in 23 nodules (82.1%) using VATS. The average duration of the ENB-guided pleural dye marking procedure was 12.6 min (range, 4–30 min). The resection margins were negative in all malignant nodules. Complications unrelated to the ENB-guided localisation procedure occurred in two patients, including one case of haemorrhage and one case of slow intraoperative heart rate.ConclusionENB can be used to safely and accurately locate small peripheral pulmonary nodules and guide surgical resection.Trial registration numberChiCTR1900021963.

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Gamma Probe-Guided Thoracoscopic Surgery of Small Pulmonary Nodules

Tumori Journal ◽

10.1177/030089160008600432 ◽

2000 ◽

Vol 86 (4) ◽

pp. 364-366 ◽

Cited By ~ 9

Author(s):

Giuseppe Boni ◽

Calogero Riccardo Bellina ◽

Mariano Grosso ◽

Marco Lucchi ◽

Gianpiero Manca ◽

...

Keyword(s):

Gamma Ray ◽

Thoracoscopic Surgery ◽

Frozen Section ◽

Hot Spot ◽

Gamma Probe ◽

Pulmonary Nodules ◽

Resection Margins ◽

Histopathological Diagnosis ◽

Ionic Contrast ◽

Small Pulmonary Nodules

Video-assisted thoracic surgery (VATS) is an interesting and emerging procedure for the diagnosis and treatment of peripheral pulmonary nodules. We developed a new radioguided surgical technique for the detection during VATS of pulmonary nodules smaller than 2 cm, situated deep in the lung parenchyma and neither visible nor palpable with endoscopic instruments. The procedure is divided into two phases. Two hours before surgery 0.3 ml of a solution composed of 0.2 mL of 99mTc-labeled human serum albumin microspheres (5–10 MBq) and 0.1 mL of non-ionic contrast is injected into the lesion under CT guidance. Then the patient is submitted to VATS. During thoracoscopy a collimated probe of 11 mm diameter connected to a gamma ray detector is introduced via an 11.5 mm trocar and the pleural surface of the suspected area is scanned. A hot spot indicates the presence of the radiolabeled nodule and hence the area to be resected. We treated 39 patients with small pulmonary nodules (mean size, 8.3 mm; range, 4–19 mm). The patients were 27 men and 12 women (mean age, 60.8 years; range, 13–80 years). Nineteen patients had a history of synchronous or metachronous malignancy. In all cases the nodule was detected and resected and the resection margins were pathologically free of tumor. Histological examination showed 21 benign and 18 malignant lesions (7 metastases and 11 primary lung cancers). Nine patients with a frozen section-based histopathological diagnosis of lung cancer without functional contraindications underwent a completion lobectomy by open surgery in the same surgical session. In conclusion, the radiolocalization of small pulmonary nodules by gamma probe during VATS is a safe and easy procedure, with fewer complications and a lower failure rate than other localization techniques.

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AB013. Learning curve of image-guided video-assisted thoracoscopic surgery for small pulmonary nodules: a prospective analysis of thirty initial patients

Journal of Thoracic Disease ◽

10.21037/jtd.2017.s013 ◽

2017 ◽

Vol 9 (S14) ◽

pp. AB013-AB013 ◽

Cited By ~ 1

Author(s):

Hsin-Yueh Fang ◽

Ming-Ju Hsieh ◽

Chih-Tsung Wen ◽

Yin-Kai Chao

Keyword(s):

Learning Curve ◽

Thoracoscopic Surgery ◽

Pulmonary Nodules ◽

Prospective Analysis ◽

Image Guided ◽

Video Assisted ◽

Small Pulmonary Nodules ◽

Video Assisted Thoracoscopic Surgery

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Primary results, NRG Oncology/NSABP B-35: A clinical trial of anastrozole (A) versus tamoxifen (tam) in postmenopausal patients with DCIS undergoing lumpectomy plus radiotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.18_suppl.lba500 ◽

2015 ◽

Vol 33 (18_suppl) ◽

pp. LBA500-LBA500 ◽

Cited By ~ 6

Author(s):

Richard G. Margolese ◽

Reena S. Cecchini ◽

Thomas B. Julian ◽

Patricia A. Ganz ◽

Joseph P. Costantino ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Distant Recurrence ◽

Phase Iii ◽

Resection Margins ◽

Second Primary ◽

Second Primary Cancers ◽

Point Estimates ◽

Secondary Endpoints

LBA500 Background: The primary endpoint of NSABP B-35, a phase III trial comparing 1 mg/day anastrozole to 20 mg/day tamoxifen, each given for 5 years, was breast cancer-free interval (BCFI), defined as the time from randomization to any breast cancer (BC) event including local, regional, or distant recurrence or contralateral disease, invasive or DCIS. Methods: Postmenopausal women with ER-receptor or PgR-receptor positive (by IHC analysis) DCIS and no invasive BC who had undergone a lumpectomy with clear resection margins were randomly assigned to receive either 20 mg/day tam or 1 mg/day A (blinded) for 5 years. Stratification was by age (<60 v ≥60). Results: From 1/6/2003 to 6/15/2006, 3,104 pts were entered and randomized (1552 in groups tam and A each). As of 2/28/15, follow-up information was available on 3,083 pts for OS and on 3,077 pts for all other disease-free endpoints, with mean time of follow-up of 8.6 years. There were 198 BCFI events, 114 in the tam group and 84 in the A group (HR, 0.73; p=0.03). 10-year point estimates for BCFI were 89.2% for tam and 93.5% for A. A significant time-by-treatment interaction (p=0.02) indicated that the effect was not evident until later in the study. There was a significant interaction between treatment and age group (p=0.04); benefit of A is only in women <60 years old. As to secondary endpoints, there were 495 DFS events, 260 in the tam group and 235 in the A group (HR, 0.89; p=0.21). 10-year point estimates for DFS were 77.9% for tam and 82.7% for A. There were 186 deaths, 88 in the tam group and 98 in the A group (HR, 1.11; p=0.48). 10-year point estimates for OS were 92.1% for tam, 92.5% for A. There were 8 deaths due to breast cancer in the tam group and 5 in the A group. There were 63 cases of invasive breast cancer in the tam group and 39 in the A group (HR, 0.61; p=0.02). There was a non-significant trend for a reduction in breast second primary cancers with A (HR, 0.68; p=0.07). Conclusions: Anastrozole provided a significant improvement compared to tamoxifen for BCFI, which was seen later in the study, primarily in women <60 years. Support: CA12027, 37377, 69651, 69974; 180868, 180822, 189867 196067, 114732; AstraZeneca Pharmaceuticals LP. Clinical trial information: NCT00053898.

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Prevalence of tuberculosis in small pulmonary nodules obtained by video-assisted thoracoscopic surgery

Respiratory Medicine ◽

10.1016/j.rmed.2005.05.004 ◽

2006 ◽

Vol 100 (2) ◽

pp. 238-243 ◽

Cited By ~ 4

Author(s):

Noriko Hosaka ◽

Mitsuaki Kameko ◽

Hideki Nishimura ◽

Shigetoshi Hosaka

Keyword(s):

Thoracoscopic Surgery ◽

Pulmonary Nodules ◽

Video Assisted ◽

Small Pulmonary Nodules ◽

Video Assisted Thoracoscopic Surgery

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Application of Modified Tailed Microcoil in Preoperative Localization of Small Pulmonary Nodules: A Retrospective Study

The Thoracic and Cardiovascular Surgeon ◽

10.1055/s-0040-1708471 ◽

2020 ◽

Vol 68 (06) ◽

pp. 533-539

Author(s):

Saisai Sun ◽

Kaichao Liu ◽

Xiang Gao ◽

Binhui Ren ◽

Lei Sun ◽

...

Keyword(s):

Methylene Blue ◽

Thoracoscopic Surgery ◽

Pulmonary Nodules ◽

Operation Time ◽

Preoperative Localization ◽

Visceral Pleura ◽

Pleural Adhesion ◽

Significant Difference ◽

Male Patients ◽

Small Pulmonary Nodules

Abstract Background The localization of small pulmonary nodules (SPNs) during video-assisted thoracoscopic surgery (VATS) is challenging thoracic surgeon, especially in patients with severe pleural adhesion or visceral pleura pigmentation due to low success rate and future conversion to thoracotomy. This study aims to compare the efficacy and safety between modified microcoil and methylene blue in preoperative localization of small nodules, particularly patients with severe pleural adhesion or visceral pleura pigmentation. Materials and Methods From January 2018 to February 2019 in our institute, 342 patients who underwent computed tomography-guided localization of SPN were recruited in this retrospective cohort study and divided into the modified microcoil group (n = 239) and the methylene blue group (n = 103) according to the localization method. Clinical characteristics and perioperative complications were collected to analyze. Results All SPNs were successfully marked in both groups. Location-related complications, the duration of localization procedure, and the length of hospital stay were not different between the two groups. The operation time of modified microcoil and the duration of removal of nodule in operation were both shorter than the methylene blue (p = 0.014 and p = 0.047). The analysis stratified by gender showed that similar results were found in male patients (p = 0.01 and p = 0.00), while in female patients, no significant difference was found. Additionally, in senior patients (older than 60 years), the operation time in modified microcoil groups was less than methylene blue group (p = 0.024). Conclusion Compared with methylene blue, modified microcoil achieved a shorter operation time of removal of nodule in VATS, especially for patients with pleural adhesion and the pigmentation of the lung surface as well as the male patients and the patients older than 60 years.

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