Heat production during pulmonary artery sealing with energy vessel-sealing devices in a swine model.

OBJECTIVES: Energy vessel-sealing devices are being increasingly utilized to seal pulmonary artery (PA) branches during lobectomy. Heat from these devices can potentially injure surrounding tissues. We evaluated heat production from devices in a live animal model. METHODS: PA branches were sealed in pigs with 4 energy vessel-sealing devices: 2 ultrasonic (US), 1 advanced bipolar or 1 mixed US and bipolar (mixed) device. Thermocouples were implanted in tissue surrounding the PA branch being sealed to measure tissue temperature. A thermal camera measured the sealing site and the temperatures of the instruments. Pathological analysis was performed on PA stumps to identify thermal damage. RESULTS: A total of 37 PA branches were sealed in 4 pigs. Maximum tissue heat measured by the thermocouples for the 2 US, advanced bipolar and mixed devices was 42, 39, 42 and 46°C, respectively. The mean tissue temperatures at the site of the sealing measured with the thermal camera were 78, 75, 70 and 82°C (P = 0.834) and the mean instrument blade temperatures were 224, 195, 83 and 170°C (P = 0.000005) for the 2 US, advanced bipolar and mixed devices, respectively. The mean diameter of the region with tissue reaching 60°C or more measured with the thermal camera was between 4 and 6 mm for the 4 devices (P = 0.941). On pathological analysis, PA stumps had either thermal damage on the adventitia and external media (26/37) or transmural damage (11/37) at 1 mm from sealed site. CONCLUSIONS: A 3-mm safety margin between the instrument blades and vital structures is recommended. Instrument blades can reach high temperatures that may cause tissue damage.

Diagnostic Accuracy of Mediastinal Lymph Node Staging Techniques in the Preoperative Assessment of Nonsmall Cell Lung Cancer Patients.

BACKGROUND: Nonsmall cell lung cancer (NSCLC) treatment is based on an accurate staging. Mediastinal lymph nodes staging has a critical impact on treatment management. METHODS: The objective was to assess the current accuracy of preoperative tools for predicting mediastinal and hilar lymph nodes staging with NSCLC. Retrospective analysis of 997 biopsy-proven NSCLC patients treated at a single academic medical center between January 2006 and April 2012. Mediastinal lymph nodes were evaluated with preoperatively with: computed tomography (CT), positron emission tomography (PET), endobronchial ultrasound-guided fine needle aspiration, and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). Results are compared with pathologic surgical biopsy. RESULTS: A total of 217 cervical mediastinoscopies, 15 anterior mediastinotomies, and 952 surgical lymphadenectomies were performed. The sensitivity of CT scan for mediastinal lymph nodes detection was 18.9% and PET-CT scan was 33.8%. Specificities were 94.9% and 93.8%, respectively. For hilar lymph nodes detection, CT was less sensitive (17.0% vs. 39.7%); however, more specific (94.7% vs. 80.3%) than PET-CT. Endobronchial ultrasound-guided fine needle aspiration (72.7% sensitivity and 100% specificity) and endoscopic ultrasound-guided fine needle aspiration (51.9% sensitivity and 100% specificity) both demonstrated superior results. CONCLUSIONS: The majority of biopsy-proven mediastinal lymph nodes metastases are not associated with positive results on preoperative CT or PET. CT and PET have low positive predictive value for mediastinal lymph node. This study supports the routine utilization of invasive mediastinal lymph nodes staging in NSCLC, especially for patients with tumors of >4 cm diameter, regardless of CT or PET-CT results.

Phase 1 Trial Evaluating Safety of Pulmonary Artery Sealing With Ultrasonic Energy in VATS Lobectomy.

BACKGROUND: Energy-sealing devices may be useful to divide small pulmonary arteries (PAs) during video-assisted thoracoscopic surgery (VATS) lobectomy. We evaluated the safety of PA branch sealing with an ultrasonic energy vessel-sealing device during VATS lobectomy. METHODS: The study consisted of a phase 1 trial. Patients planned to undergo VATS lobectomy were prospectively enrolled. Target sample size was 20 patients. Branches of 7 mm or less were sealed and cut with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative, in-hospital, and 30-day postoperative bleeding were prospectively recorded. RESULTS: Thirty-three patients were prospectively enrolled. Thirteen patients were not amenable to PA sealing with the vessel-sealing device because all PA branch diameters exceeded 7 mm (n = 10), conversion to thoracotomy (n = 2), and lobectomy not performed (n = 1). A minimum of one PA branch was sealed with the device in 20 patients. Fifty-eight PA branches were divided in 20 patients: 31 with ultrasonic device, 24 with endostaplers, 2 with clips, and 1 with sutures. The mean vessel diameter sealed with the device was 4 mm. Two patients were converted to thoracotomy (1 with PA injury during dissection, 1 with PA tumor invasion). No intraoperative or postoperative bleeding was related to ultrasonic PA branch sealing. No postoperative deaths occurred. CONCLUSIONS: PA branch sealing for vessels 7 mm or less was safely achieved using an ultrasonic energy vessel-sealing device in VATS lobectomy. Large-scale, prospective, multi-institutional studies are necessary before widespread clinical application of energy for PA branch sealing in VATS lobectomy.

Pulmonary artery sealing with ultrasonic energy in open lobectomy: A phase I clinical trial.

OBJECTIVE: Pulmonary artery branch sealing in video-assisted thoracoscopic surgical lobectomy is usually achieved with vascular endostaplers. Iatrogenic pulmonary artery injury may be caused by endostaplers. We evaluated the safety of pulmonary artery sealing with an ultrasonic energy vessel-sealing device in a phase I clinical trial evaluating in vivo safety of the device during open lobectomy. METHODS: Patients scheduled to undergo elective open (thoracotomy) pulmonary lobectomy were prospectively enrolled. Target sample size was 10 patients. Pulmonary artery diameter was measured intraoperatively. All branches ≤7 mm were divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative and postoperative bleeding were strictly recorded. RESULTS: Eighteen patients were prospectively enrolled. Eight patients were not amenable to pulmonary artery sealing with the device. In the 10 patients included in the analysis, a total of 14 pulmonary arteries were sealed with the ultrasonic device. The mean vessel diameter was 5 mm (range, 2-7 mm). One patient underwent reoperation for bronchial artery bleeding (vessel not sealed with device). There was no intra- or postoperative bleeding related to ultrasonic pulmonary artery sealing. There was no postoperative mortality. CONCLUSIONS: Pulmonary artery sealing for vessels with diameter ≤7 mm was safely achieved with an ultrasonic energy vessel-sealing device in open lobectomy. The use of ultrasonic energy vessel-sealing devices in video-assisted thoracoscopic surgical lobectomy may have the advantage of making small, short, pulmonary artery branch sealing safer than with vascular endostaplers. Further studies are necessary before widespread application in lobectomy, including video-assisted thoracoscopic surgical lobectomy.

Evaluation of the Mediastinum: Differentiating Between Stations 4L, 5, and 6 Using EBUS and EUS.

Correct identification of mediastinal lymph node stations with endoscopic ultrasound (EUS) and endobronchial ultrasound (EBUS) requires knowledge of their ultrasonic anatomical positions and relations. The ultrasonic positions of the lymph node stations located in and around the aortopulmonary window (stations 4L, 5, and 6) can be more challenging to understand. The aim of this report is to describe the endosonographic anatomic positions of stations 4L, 5, and 6 and to demonstrate their locations using EUS and EBUS.

Endobronchial and Endoscopic Ultrasound-Guided Transvascular Biopsy of Mediastinal, Hilar, and Lung Lesions.

BACKGROUND: Endoscopic techniques, including endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS), are the initial approach for the diagnosis and staging of lung cancer and the diagnosis of mediastinal and hilar lesions. Historically, the transvascular approach has been avoided because of concerns of bleeding. Here we review our experience with EBUS and EUS transvascular biopsy of mediastinal, hilar, and lung lesions. METHODS: A prospective research database was used to retrospectively identify and review the records 33 consecutive patients who underwent EBUS and EUS transvascular biopsy in an outpatient setting over 4 years. Complications were identified as significant hematoma seen with endoscopic ultrasound, hemothorax, hemoptysis other than minor, hemodynamic instability, hospital admission, and death. RESULTS: The biopsies in 14 patients were performed through branches of the pulmonary artery, and 19 were done through the aorta. All EUS biopsies were performed with a 22-gauge needle, and all EBUS biopsies were performed with a 21-gauge needle. Malignancy was diagnosed with specimens from a transvascular biopsy in 16 patients (48.5%). Samples from 8 biopsies (24%) were described as negative for malignancy, and 9 specimens (27%) were described as insufficient. No complications were seen in the immediate postprocedural period, and all 33 patients were discharged home the same day. The median follow-up after the procedure was 12 months, with no complications described. The overall yield was 73%. CONCLUSIONS: In this series, EBUS- and EUS-guided transvascular approach for biopsy of mediastinal, hilar, and lung lesions was not associated with significant complications. However, careful selection of potential candidates and close periprocedural observation are mandatory.

Pulmonary Artery Sealing With an Ultrasonic Energy Device in Video-Assisted Thoracoscopic Surgery Lobectomy: An Animal Survival Study.

BACKGROUND: Pulmonary artery (PA) sealing in video-assisted thoracoscopic surgery (VATS) lobectomy is typically accomplished using vascular endostaplers. Endostaplers may be associated with iatrogenic PA branch injury, especially in short, small PA branches. We evaluated PA branch sealing with the HARMONIC ACE +7 (ACE) shears (Ethicon, Cincinnati, OH) in VATS lobectomy in a canine survival model. METHODS: Ten adult dogs underwent VATS lobectomy. Standard VATS lobectomy operative technique was used for the entire operation, except for PA branch sealing. The ACE was used for all PA branch sealing. Dogs were kept alive for 30 days. RESULTS: The 10 dogs underwent VATS right upper (n = 5) and right lower (n = 5) lobectomy. The ACE was used to seal 21 PA branches. No PA branch was divided with an endostapler. There were no intraoperative complications or conversions to thoracotomy. Mean in vivo PA diameter was 5.6 mm (range, 2 to 12 mm). One 10-mm PA branch had a partial seal failure immediately at the time of sealing. The device was reapplied on the stump, and the PA branch was successfully sealed. All dogs survived 30 days without hemothorax. Necropsy at 30 days did not reveal any signs of postoperative bleeding. Pathology of the sealed PA branches at 30 days revealed fibrosis, giant cell reaction, neovascularization, and thermal changes of the vessel wall. CONCLUSIONS: The use of the ACE for PA branch sealing in VATS lobectomy is safe and effective in an animal survival model. Human studies are needed to determine the clinical safety of ultrasonic PA branch sealing before widespread clinical use.

Palliation of Concomitant Tracheobronchial and Esophageal Disease Using a Combined Airway and Esophageal Approach.

BACKGROUND: Neoplastic involvement of the mediastinum can contribute to both airway and esophageal pathology. That can manifest as combined esophageal and airway stenosis, or tracheobronchoesophageal fistula. Conventional palliative treatment of these problems consists of endoluminal stent insertion. The double stenting approach consists of insertion of a tracheobronchial and an esophageal stent in parallel and allows concomitant symptomatic relief of both the airway and esophageal pathology. METHODS: The study consists of a retrospective case series of patients who underwent a double stenting procedure for concomitant airway and esophageal disease between August 2009 and September 2014. The type of airway stent chosen was determined based on the pathology and the level of the lesion (simple tubular in the mid trachea or mainstem bronchus, Y-stent for carina). RESULTS: Thirty-nine patients were treated using the double stenting approach during a combined procedure over 5 years: 15 patients with tracheobronchoesophageal fistula and 24 with stenosis. Immediate relief of symptoms, defined as resuming oral intake and breathing without an external tracheal device, was observed in 25 patients (64%). Thirty-two patients (82%) were discharged from hospital, and 7 patients died in hospital (18%). Of these 7 deaths, 6 patients died of pulmonary complications. Inhospital complications occurred in 11 patients (28%). Of the patients discharged from the hospital, 14 died during a mean follow-up period of 54 days. Mean and median survival were 49 and 24 days, respectively (range, 1 to 448), and median hospital stay was 3 days (range, 1 to 46). CONCLUSIONS: Treatment of combined airway and esophageal pathology using a double stenting approach is safe, feasible, provides reasonable immediate palliation of symptoms, and is associated with acceptable morbidity. It is a palliative procedure that allows for early hospital discharge of patients who are diagnosed with an incurable malignancy.

Endoscopic Mediastinal Staging in Lung Cancer Is Superior to "Gold Standard" Surgical Staging.

BACKGROUND: The objective was to evaluate whether endobronchial ultrasonography (EBUS) or endoscopic ultrasonography (EUS) staging techniques of the mediastinum for lung cancer can change the treatment plan compared with the "gold standard" of surgical staging. METHODS: Patients were retrospectively identified from a prospectively collected database. Endoscopic staging was compared with the "gold standard" cervical mediastinoscopy (CM). In cases where mediastinoscopy was not performed, EBUS/EUS was compared with "ideal" CM, a virtual procedure, which was assumed to have 100% rates of sensitivity and specificity. RESULTS: EBUS was performed in 324 patients (99%), EUS in 295 patients (90%), and CM in 101 patients (31%); 226 patients (69%) were assumed to have undergone a virtual ideal CM and a virtual surgical mediastinal staging; 108 positive biopsies (33.0%) with endosonography had sampling of targets that were out of the scope of CM. Distant metastatic disease was diagnosed by EBUS/EUS in 7 patients (2.1%); 22 patients (6.7%) had positive targets outside the reach of the CM or virtual CM. If the 14 patients who had positive stations 5, 6, 10, and 11 are excluded (accessible with anterior mediastinotomy or extended cervical mediastinoscopy), there were 6 patients (1.8%) in whom endosonography upstaged the patient over ideal surgical mediastinal staging. In 20 patients (6.1%), ultrasound-guided biopsy made the diagnoses, which changed the treatment plan over CM and ideal CM. CONCLUSIONS: Combined EBUS- and EUS-guided biopsies can access more targets, including lung and distant metastasis, and thus have the potential to upstage patients compared with mediastinoscopy and change the treatment plan.

Transtracheal thoracic natural orifice transluminal endoscopic surgery (NOTES) in a swine model.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has the potential to be the final frontier in minimally invasive procedures in thoracic surgery. In order for thoracic pleural NOTES to 1 day be ready for clinical trials, each step of the procedure must be independently evaluated for both safety and efficacy. The aim of this study was to evaluate the trachea as a portal of entry for thoracic NOTES. METHODS: Eight 40-kg swine underwent right thoracic pleuroscopy in a survival model. In order to avoid inadvertent injury to the superior vena cava, endobronchial ultrasound was employed to select the location of airway incision. A 7-mm linear incision was then performed at the chosen location using an endoscopic electrocautery needle knife through a therapeutic flexible videobronchoscope. The mediastinal fat and parietal pleura were then dissected with electrocautery, and complete right pleuroscopy was performed. The tracheal and mediastinal portal of entry were then sealed with 1-2 cc of fibrin sealant. The pigs were kept alive for 21 days postoperatively. Postmortem diagnostic bronchoscopy was performed to assess tracheal healing. All tracheal specimens underwent histologic examination for healing and signs of mediastinal infection. RESULTS: Thoracic NOTES procedures on all eight pigs were successful. There were no intraoperative complications except for one minor bleeding episode within the mediastinal dissection site which stopped spontaneously. Two pigs died from severe laryngospasm in the early postoperative period. Six pigs survived for 21 days post-procedure and experienced uneventful postoperative courses. Postmortem examination demonstrated complete tracheal healing with appropriate scarring in all pigs. CONCLUSIONS: The trachea appears to be a safe port of entry for thoracic NOTES procedures in a swine model. Smaller tracheal incisions followed by balloon dilatation are associated with less postoperative morbidity and mortality. Tracheal incisions sealed with fibrin sealant healed rapidly and without signs of mediastinal infection. This procedure represents a work in progress and is not yet ready for human trials.

Self-expanding metallic stent placement with an exaggerated 5-cm proximal tumor covering for palliation of esophageal cancer.

BACKGROUND: The study aimed to evaluate the short- and long-term outcomes with a technique of self-expanding metallic stent insertion in palliative esophageal cancer patients. We hypothesized that a systematic attempt at exaggerated (5 cm) proximal tumor covering could prevent both stent migration and tumor overgrowth/undergrowth. METHODS: We reviewed retrospectively all patients who underwent esophageal stenting for palliation of malignant dysphagia over a 24-month period. Consecutive patients were identified from a prospective thoracic surgery interventional endoscopy database. This technique consisted of endoscopic stent insertion with the aim of landing the proximal portion of the stent 5 cm cephalad to the proximal extent of the tumor. All patients were followed at one month post-procedure and every three months thereafter, until death. Short- and long-term complications associated with the procedure and mortality were evaluated. RESULTS: Forty seven patients underwent endoscopic insertion of an esophageal stent in the context of an inoperable esophageal cancer using this technique over a 24-month period. The mean age was 70.4±9.6 years. Four (8.5%) patients underwent re-stenting due to proximal tumor overgrowth. No stent migration, perforation, tumor ingrowth or stent occlusion was reported. The mean patient survival was 146±26.5 days. CONCLUSIONS: Esophageal stent insertion under endoscopic guidance with proximal tumor covering of 5 cm is effective and safe. No cases of stent migration and a low incidence of tumor overgrowth/undergrowth were observed with this technique.

Pulmonary Artery Sealing Using the HARMONIC ACE+ Shears for Video-Assisted Thoracoscopic Surgery Lobectomy.

BACKGROUND: The standard technique for pulmonary arterial (PA) branch sealing in video-assisted thoracoscopic surgery lobectomy consists of vascular endostaplers. We evaluated the immediate efficacy of an ultrasonic energy vessel-sealing device for sealing PA branches and compared it with the gold standard (endostapler) in an ex vivo model. METHODS: This was a prospective cohort study. Immediately after anatomical lung resection, PA vessel sealing was achieved using the HARMONIC ACE+ Shears (ACE; Ethicon, Cincinnati, OH) sealing device or a vascular endostapler (VES) in a 3:1 ratio based on vessel diameter. The vessel was slowly pressurized, and the bursting pressure was recorded. RESULTS: A total of 137 PA branches were sealed in specimens from 43 patients, of which 90 vessels were sealed with ACE and 47 were sealed with VES. The mean PA branch diameter was 6.0 mm (range, 1.7 mm to 24.0 mm; standard deviation, 3.1 mm Hg). The mean bursting pressure was 333.0 mm Hg (range, 84.0 mm Hg to 1415.1 mm Hg; standard deviation, 231.4 mm Hg) in the ACE group and 114.2 mm Hg (range, 0 mm Hg to 840.0 mm Hg; standard deviation, 124.7) in the VES group (p < 0.001). There were no complete sealing failures in the ACE group. Electron microscopy of ACE-sealed PA vessels demonstrated adventitial sealing with partial preservation of the collagen bundles and media with a sealed matrix of melted collagen. CONCLUSIONS: PA branches sealed using the HARMONIC ACE+ in a simulated ex vivo model were able to sustain high intraluminal pressures. ACE-sealed vessels burst at mean bursting pressures equal to or greater than the VES-stapled vessels.

Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model.

OBJECTIVE: Vascular endostaplers are bulky and can be dangerous when dividing small pulmonary arterial (PA) branch vessels during video-assisted thoracoscopic lobectomy. We aimed to evaluate and compare the immediate efficacy of modern energy sealing devices in an ex vivo PA sealing model. METHODS: Patients undergoing anatomical lung resection or lung transplantation were recruited for a prospective cohort pilot study. Four devices were evaluated: Harmonic Ace (Ethicon, Cincinnati, Ohio), Thunderbeat (Olympus, Tokyo, Japan), LigaSure (Covidien, Boulder, Colo), and Enseal (Ethicon; Cincinnati, Ohio). After anatomical lung resection, the PA branches were dissected in vitro. Sealing was then performed with 1 of the sealing devices, the vessel was slowly pressurized, and the bursting pressure was recorded. RESULTS: Forty-nine PA branches were sealed in 14 patients. The mean PA branch diameter was 7.4 mm (1.8-14.5 mm). Ten patients had normal PA pressure and 3 had PA hypertension. The mean bursting pressure in each was as follows: Harmonic Ace group, 415.5 mm Hg (137.1-1388.4 mm Hg), Thunderbeat group, 875 mm Hg (237.1-2871.3 mm Hg); LigaSure group, 214.7 mm Hg (0-579.6 mm Hg); Enseal group, 133.7 mm Hg (0-315.38 mm Hg). There were 2 complete sealing failures: LigaSure (diameter 6.78 mm) and Enseal (diameter 8.3 mm). CONCLUSIONS: In this pilot study to examine energy sealing of PA branches in a simulated ex vivo model, vascular sealing using energy was effective and was able to sustain high intraluminal bursting pressures. Further research is needed to determine the in vivo and long-term safety of PA branch energy sealing.

Preoperative assessment of chest wall invasion in non-small cell lung cancer using surgeon-performed ultrasound.

BACKGROUND: Chest wall invasion in operable lung cancer upgrades the stage and can affect operative planning. Diagnosing chest wall invasion preoperatively is important in patient consent, in the choice of operative incision placement, and can be helpful in choosing an operative approach (open vs thoracoscopic). The objectives of this study were to determine the diagnostic accuracy of preoperative, surgeon-performed ultrasound (US) in assessing tumoral chest wall invasion (T3) in non-small cell lung cancer (NSCLC) patients and to compare its accuracy vs preoperative computed tomography (CT). METHODS: This study was a prospective clinical trial (ClinicalTrials.gov: NCT01206894) that prospectively enrolled patients between September 2010 and January 2013. Eligible patients included those with NSCLC abutting the parietal pleura or invading the chest wall on preoperative CT scan of the chest and who were planned for surgical resection. Criteria for chest wall invasion on US included (1) disruption of the parietal pleura, (2) invasion of the ribs, or (3) impairment of pleural movement with respiration. The US chest wall examination was performed by the thoracic surgical team immediately before the surgical intervention. Sensitivity and specificity for CT scan and US in assessing chest wall invasion were calculated using definitive chest wall invasion on final pathologic analysis as the gold standard for chest wall invasion. RESULTS: During a 28-month period, 28 patients (15 men and 13 women) patients were prospectively enrolled. Mean age was 62 ± 11 years, and mean body mass index was 25.3 ± 4.5 kg/m(2). The average time for surgeon-performed US assessment looking for chest wall invasion was 5.3 ± 5 minutes. The sensitivity of US in evaluating chest wall invasion was 90.9% and the specificity was 85.7%. CT scan was associated with a sensitivity of 61.5% and a specificity of 84.6%. The positive and negative predictive values of surgeon-performed US for tumoral chest wall invasion were 83.3% and 92.3%, respectively, compared with 80% and 68.8% for CT scan. CONCLUSIONS: Surgeon-performed preoperative chest wall US can reliably diagnose tumoral chest wall invasion in patients with NSCLC. CT scan has poor sensitivity in predicting chest wall invasion preoperatively. Surgeon-performed US can be considered as a complementary adjunct to preoperative imaging in patients with pulmonary lesions abutting the chest wall to improve preoperative diagnosis, staging, and operative planning.

Endosonographic mediastinal lymph node staging of lung cancer.

BACKGROUND: It is unclear whether endoscopic mediastinal lymph node (LN) staging techniques are equivalent to surgical mediastinal staging (SMS) techniques in patients with potentially operable non-small cell lung cancer (NSCLC). METHODS: A total of 166 patients with confirmed or suspected NSCLC who required SMS based on current guidelines were enrolled in this prospective controlled trial comparing endosonographic mediastinal LN staging with SMS. Each patient served as his or her own control. All patients underwent endobronchial ultrasound (EBUS), endoscopic ultrasound (EUS), and SMS during a single procedure. Results of EBUS, EUS, and combined EBUS/EUS were compared with SMS (gold standard) and in patients with negative LN staging results, with LN sampling at pulmonary resection. RESULTS: EBUS, EUS, combined EBUS/EUS, and SMS sampled a mean of 2.2, 1.7, 3.9, and 3.1 LN stations, respectively. The prevalence of mediastinal nodal disease (N2/N3) was 32% (53 of 166 patients). The sensitivity, negative predictive value, and diagnostic accuracy of the endoscopic staging modalities, respectively, were EBUS, 72% (95% CI, 0.58-0.83), 88% (0.81-0.93), and 91% (0.85-0.95); EUS, 62% (0.48-0.75), 85% (0.78-0.91), and 88% (0.82-0.92); and combined EBUS/EUS, 91% (0.79-0.97), 96% (0.90-0.99), and 97% (0.93-0.99). Endosonography was diagnostic for N2/N3/M1 disease in 24 patients in whom SMS findings were negative, preventing futile thoracotomy in an additional 14% of patients. CONCLUSIONS: The combined EBUS/EUS procedure can replace surgical mediastinal staging in patients with potentially resectable NSCLC. Additionally, endosonography leads to improved staging compared with SMS because it allows the biopsy of LNs and metastases unattainable with SMS techniques. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01011595; URL: www.clinicaltrials.gov.

Pleural ultrasound as an adjunct to physical examination in the preoperative evaluation of lung cancer patients.

OBJECTIVES: Preoperative evaluation of patients with suspected or confirmed lung cancer consists of clinical and radiological staging. Malignant pleural effusion is a poor prognosticator in non-small-cell lung cancer. Pleural ultrasound (PU) allows for the assessment of pleural effusion, providing real-time guidance for its aspiration and cytological analysis. Pleural Ultrasonography in Lung Cancer (PULC) as an adjunct to physical examination has the potential to improve preoperative staging of non-small-cell lung cancer during first surgical encounter by allowing the evaluation of previously unassessed pleural effusion. METHODS: This study consisted of a prospective trial of surgeon-performed PU in the preoperative evaluation of lung cancer patients. All patients evaluated in the thoracic surgery clinic with the new or presumed diagnosis of lung cancer were eligible. A portable ultrasound machine was used to evaluate pleural fluid in the bilateral costophrenic sulci with pleural fluid aspiration for cytological analysis. RESULTS: Forty-five patients were prospectively enrolled over a 3-month period. Thirteen patients had ultrasound evidence of a pleural effusion, of which 3 were significant enough for aspiration. Cytological analysis of these effusions yielded malignant cells in 1 patient. Positive PULC evaluation led to a change in clinical staging (M0 to M1a) in 10 patients and a change in pathological staging (pleural fluid cytology positive) in 1 patient. The time required for PULC examination was 15 ± 7 min. There were no complications related to the procedures. CONCLUSIONS: Preoperative pleural ultrasonography is a rapid and effective way to improve precision of staging in patients with lung cancer. More precise staging may allow for more appropriate testing, patient prognostication and operative planning.

Endobronchial ultrasonography added to endoscopic ultrasonography improves staging in esophageal cancer.

BACKGROUND: The gold standard for staging the local extension (T stage) and lymph node (LN) status (N stage) of esophageal cancer is endoscopic ultrasonography (EUS). When biopsy of the peritumoral LNs is performed using EUS, there is a risk of specimen contamination secondary to piercing the primary tumor; this shortcoming can be circumvented with endobronchial ultrasonography (EBUS). Moreover, EBUS allows for biopsy of LN stations not accessible with EUS. METHODS: The study consisted of a prospective clinical trial. Fifty-two consecutive patients with potentially resectable esophageal cancer referred for endoscopic staging were prospectively enrolled. Radial and convex EUS followed by convex EBUS were performed during a single staging procedure. The LNs not accessible by EUS were biopsied using EBUS. Results of the EBUS procedure were compared to those of EUS in terms of the addition of staging information, upstaging, and confirmation of stage. RESULTS: The combined EBUS-EUS procedure was performed in 42 patients. Ten patients were excluded. In all, 54 LNs were biopsied under EUS guidance and 48 LNs were biopsied under EBUS guidance. The EUS results were positive for metastatic esophageal cancer in 29 LNs (54%), and EBUS was positive in 10 LNs (21%). The addition of EBUS to EUS in the staging of esophageal cancer led to nodal and patient upstaging in 5 patients (12%) and confirmed the EUS stage with additional negative or positive LN sampling in 29 patients (69%). Positive EBUS that led to upstaging (5 patients) changed the treatment plan from potentially resectable to palliative. There was no morbidity related to EBUS. CONCLUSIONS: A combined EBUS-EUS staging procedure improves precision in staging, leads to upstaging, and can change the treatment plan in patients with esophageal cancer.

Initial experience with a new technique of endoscopic and ultrasonographic access for biopsy of para-aortic (station 6) mediastinal lymph nodes without traversing the aorta.

OBJECTIVES: All lymph node stations but the para-aortic are accessible by a combination of endoscopic ultrasound and endobronchial ultrasound. We recently described an echographic-endoscopic technique for the biopsy of para-aortic (station 6) lymph nodes without traversing the thoracic aorta. This study reviewed our initial experience with this new technique. METHODS: This first-in-human evaluation of the biopsy of station 6 mediastinal lymph nodes with curvilinear endoscopic ultrasound without arterial puncture used a retrospective case series design to study 12 consecutive patients who underwent this new technique. Station 6 lymph nodes were approached with a long fine needle aspiration approach (6-8 cm) through the proximal esophagus. The needle was passed through the esophagus into the mediastinum just medial to the left subclavian artery. It was then directed toward the para-aortic location (6-8 cm trajectory) to reach and enter the para-aortic lymph nodes without piercing the aorta or great vessels. RESULTS: Successful cytologic diagnoses of station 6 lymph nodes were obtained in all cases (lymphocytes in all samples). No morbidity resulted from the procedure, nor was any observed at 30 days after the procedure. Patient anatomy may preclude safe access in certain situations. CONCLUSIONS: Endoscopic ultrasound access of para-aortic (station 6) lymph nodes allows complete, minimally invasive mediastinal lymph node staging and diagnosis without traversal of the aorta. This technique, the final piece of the puzzle required for complete staging of the mediastinum with nonsurgical endoscopic techniques, is reproducible and safe.

Thoracoscopic localization of intraparenchymal pulmonary nodules using direct intracavitary thoracoscopic ultrasonography prevents conversion of VATS procedures to thoracotomy in selected patients.

OBJECTIVES: To investigate the feasibility, accuracy, and effect on conversion rates of intracavitary video-assisted thoracoscopic surgery ultrasonography (VATS-US) for localization of difficult to visualize pulmonary nodules. METHODS: The study consisted of a prospective cohort of VATS-US for localization of intraparenchymal peripheral pulmonary nodules. Patients with pulmonary nodules not touching the visceral pleura on the computed tomography scan, who were scheduled for VATS wedge resection, were prospectively enrolled. The lobe of interest was examined: visually, using finger palpation when possible, and using the instrument sliding method. The nodule was then sought using a sterile ultrasound transducer. The primary outcome measure was the prevention of conversion to thoracotomy or lobectomy secondary to positive VATS-US findings in patients with nodules that were not identifiable using standard VATS techniques. RESULTS: Four different surgeons performed 45 individual VATS-US procedures during a 13-month period. Intracavitary VATS-US was able to detect 43 of 46 nodules. The sensitivity of VATS-US was 93%, and the positive predictive value was 100%. The lung nodules were visualized by thoracoscopic lung examination in 12 cases (27%), palpable by finger in 18 cases (40%), and palpable using the instrument sliding technique in 17 cases (38%). In 20 cases, lung nodules were not identifiable using any of the traditional techniques and were identified only with VATS-US. VATS-US, therefore, prevented conversion to thoracotomy or lobectomy without tissue diagnosis in 43% (20/46) of cases. CONCLUSIONS: Intracavitary VATS-US is a real-time, feasible, reliable, and effective method of localization of intraparenchymal pulmonary nodules during selected VATS wedge resection procedures and can decrease the conversion rates to thoracotomy or lobectomy.