Feasibility study of cryobiopsy for practical pathological diagnosis of primary lung cancer including immunohistochemical assessment.

BACKGROUND: Precision medicine in non-small cell lung cancer requires attainment of a sufficient amount of high-quality tumor tissue. Transbronchial cryobiopsy has emerged as a new diagnostic method for non-neoplastic lung disease with a better potential to assess morphology compared with conventional methods. However, the influence of cryobiopsy on specimen quality, particularly detection of protein expression, is unknown. We performed a comparative immunohistochemical study in specimens obtained by cryobiopsy versus conventional sampling to evaluate the feasibility of cryobiopsy for lung cancer diagnosis. METHODS: Pairs of artificial biopsy specimens, collected using a cryoprobe or conventional scalpel, were obtained from 43 surgically resected primary lung tumors. Formalin-fixed, paraffin-embedded blocks were prepared in an ISO15189-certified laboratory. Immunohistochemical staining of thyroid transcription factor-1, p40, Ki67 and programmed death-ligand 1 (22C3) was performed. The H-scores for thyroid transcription factor-1 and p40, labeling index for Ki67 and tumor proportion score for programmed death-ligand 1 were assessed. Pearson's correlation coefficients between two sampling types were calculated. RESULTS: The thyroid transcription factor-1 and p40 H-scores showed perfect correlations between the cryobiopsy and conventional scalpel-obtained specimens (R2 = 0.977 and 0.996, respectively). Ki67 labeling index and PD-L1 tumor proportion score also showed strong correlations between the two sample types (R2 = 0.896 and 0.851, respectively). Five cases (11.6%) exhibited differences in tumor proportion score category between sample types, potentially because of intratumoral heterogeneity. CONCLUSIONS: Immunohistochemical expression of certain tumor markers showed a high concordance between cryobiopsy and conventional scalpel sampling. Cryobiopsy is feasible for pathological diagnostics including PD-L1 evaluation.

Evaluation of histological specimens obtained by two types of EBUS-TBNA needles: a comparative study.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration is a standard method for obtaining specimens of mediastinal and hilar lesions. Several types of needles of various sizes and materials are available. This study aimed to compare the quality of specimens collected using two needles, cobalt chromium and stainless steel for endobronchial ultrasound-guided transbronchial needle aspiration. METHODS: This retrospective study included data of patients who underwent EBUS-TBNA with a 22-gauge needle made from either stainless steel (41 lesions, 121 punctures) or cobalt chromium (47 lesions, 145 punctures). Histological data per puncture, diagnostic yield per lesion, procedure time and complication rates were compared. RESULTS: There were no significant differences between the groups in the baseline characteristics of the patients or lesions or in the complication rates. The rate of diagnostic histological specimens in each sample (71.0% vs. 58.7%, P = 0.039), fewer samples with cartilage alone (1.4% vs. 6.6%, P = 0.047) and fewer samples containing cartilage (7.6% vs. 16.5%, P = 0.034) were seen in the cobalt chromium needle group than in the stainless steel needle group. In both groups, the rate of specimens that only contained blood clots in each sample and diagnostic yield per lesion were similar, but the procedure time was significantly shorter (22 min vs. 26 min, P = 0.007) in the cobalt chromium needle group. CONCLUSION: Compared with stainless steel needles, cobalt chromium needle for EBUS-TBNA showed lower cartilage contamination and a higher ratio of obtaining diagnostic specimens in each sample. Bronchoscopists should consider using the optimal needle gauges and materials for collecting adequate specimens.

The utility of transbronchial rebiopsy for peripheral pulmonary lesions in patients with advanced non-squamous non-small cell lung cancer.

BACKGROUND: Patients treated for non-squamous (non-Sq) non-small cell lung cancer (NSCLC) often require repeat biopsies to determine the optimal subsequent treatment. However, the differences between rebiopsy and initial biopsy in terms of their diagnostic yields and their ability to test the molecular profiles using bronchoscopy with radial endobronchial ultrasound guidance in patients with advanced NSCLC remain unclear. Hence, we aimed to compare the diagnostic yields and ability for molecular analyses of rebiopsies with those of initial biopsies. METHODS: We investigated 301 patients with advanced non-Sq NSCLC who underwent radial endobronchial ultrasound-guided transbronchial biopsy (TBB) for peripheral pulmonary lesions (PPLs) between August 2014 and July 2017. Patients were divided into the rebiopsy and initial biopsy groups: the latter referred to the biopsy that determined the definitive diagnosis. The diagnostic yields and ability for molecular analyses were compared between the two groups, and the factors affecting the TBB diagnostic yield were identified using univariate and multivariate analyses. RESULTS: The diagnostic yields of the rebiopsy and initial biopsy groups were comparable (86.8 and 90.8%, respectively; p = 0.287). Furthermore, 93.0 and 94.0% of the patients in the rebiopsy and initial biopsy groups, respectively, had adequate specimens for gene profiling and mutational analysis (p = 0.765). The factors that increased the diagnostic yield were a positive bronchus sign (p < 0.001) and tumour location within the internal two-thirds of the lungs (p = 0.026). CONCLUSIONS: The PPL diagnostic yield of the rebiopsy group was as high as that of the initial biopsy group. Hence, TBB for PPLs is feasible for patients requiring rebiopsy as well as for those with initial diagnoses. Adequate, high-quality biopsy specimens can be obtained by transbronchial rebiopsy for molecular testing.

A case report of aspergillosis accompanied by saccular bronchodilation after bronchial thermoplasty in a 19-year-old woman.

BACKGROUND: Fungal infections are rarely reported as a complication of bronchial thermoplasty (BT) in patients without immunosuppressive comorbidity. CASE PRESENTATION: A 19-year-old woman college student was admitted to our hospital owing to uncontrolled severe asthma despite using the maximum dose of steroid inhalation. She experienced asthmatic attacks more frequently while cheerleading, which is an extracurricular activity. She received BT because she wanted to continue cheerleading. After the second BT session, she developed more sputum and cough. During the third session, white secretion and saccular bronchodilation appeared in the left lower bronchus. Aspergillus fumigatus was detected in the culture of the bronchial lavage sample, and saccular bronchodilation in the affected bronchus was observed on computed tomography (CT). Five months after the start of oral itraconazole, her subjective symptoms as well as her CT findings improved. Her asthma condition improved enough for the patient to continue cheerleading without exacerbation. CONCLUSIONS: It is necessary to consider the possibility of respiratory tract infections including fungal infections after BT. Detailed observations of the entire bronchus and sample collection for microbial culture are highly recommended.

Cryobiopsy during flex-rigid pleuroscopy: an emerging alternative biopsy method in malignant pleural mesothelioma. A comparative study of pathology.

BACKGROUND: Malignant pleural mesothelioma (MPM) is rarely an asbestos-related cancer with a poor prognosis that is difficult to distinguish from some benign conditions by using conventional biopsy techniques. The purpose of this study was to evaluate the utility of a novel biopsy technique using a cryoprobe during flex-rigid pleuroscopy for diagnosing MPM. METHODS: Consecutive patients who underwent pleural cryobiopsy during flex-rigid pleuroscopy from June through November 2017 to diagnose the cause of pleural effusion were collected. From these, cases ultimately diagnosed as MPM were selected. Pleural biopsies were performed by using conventional instruments followed by a cryoprobe. The obtained samples were histologically examined and compared with regard to the quality (sample size, tissue depth, and crush rate), immunohistochemical (IHC) staining, and p16 by fluorescence in situ hybridization (FISH). RESULTS: In total, five patients ultimately diagnosed as MPM were enrolled. The sample collected was significantly larger for cryobiopsy than conventional biopsy (18.9 mm2 vs. 6.7 mm2, P < 0.001). Full-thickness biopsies were achieved in four cases by using cryobiopsy compared with one case by conventional biopsy. Moreover, the crush rate was significantly less for cryobiopsy than conventional biopsy (9% vs. 35%, P < 0.001). The results of IHC staining and p16 by FISH were similar between biopsy techniques. Cryobiopsy successfully led to accurate diagnosis of MPM in all cases, whereas conventional biopsy was diagnostic in one case. No severe complications developed after either biopsy technique. CONCLUSION: Cryobiopsy during flex-rigid pleuroscopy is a feasible and convenient biopsy technique that supports precise diagnosis of MPM.

Sterilized talc pleurodesis for malignant pleural effusions: a Phase II study for investigational new drug application in Japan.

BACKGROUND: Malignant pleural effusion is a commonly seen complication of malignancies such as lung and breast cancers. In Western countries, talc is frequently used as a standard therapeutic agent (pleurodesis agent) with the aim of alleviating symptoms including dyspnea and chest pain. Talc is not recognized as a pleurodesis agent in Japan. The aim of this study was to verify the efficacy and safety of sterilized talc (NPC-05) for the introduction of talc in Japan. METHODS: The study was a single-arm, open-label, investigator-initiated trial conducted jointly at six institutions. The subjects were 30 patients with malignant pleural effusions. A solution of 4 g NPC-05 suspended in 50 ml physiological saline was instilled into the pleural space to perform pleurodesis. RESULTS: The efficacy of NPC-05 for pleural adhesion 30 days after pleurodesis was 83.3% (25/30 cases). Amelioration of dyspnea and pain (chest pain) was seen. Commonly seen adverse effects were increased C-reactive protein (CRP) and fever. Nearly all adverse events were phenomena previously reported as adverse effects of talc. No acute respiratory distress syndrome (ARDS) or other serious side effects occurred. CONCLUSION: The efficacy and safety of NPC-05 for malignant pleural effusion in Japanese patients was verified, and the clinical outcomes with talc were confirmed to be the same as previously reported in other countries. There is thought to be a high level of need for this agent in the treatment of malignant pleural effusion in Japan.

Detection of EGFR T790M in a Large Amount of Malignant Ascites Cellblock.

Osimertinib is a highly active agent for patients with progression of lung cancer despite epidermal growth factor receptor (EGFR)tyrosine kinase inhibitor treatment. This resistance is usually due to EGFR exon 20 T790M mutation, which can be detected by repeat biopsy. We report a case in which EGFR exon 20 T790M mutation was detected by repeat ascitic fluid examination. A 71-year-old woman with lung adenocarcinoma harboring EGFR exon 19 deletion was started on erlotinib(25 mg/day)as second-line therapy. Two years later, there was increase in pleural effusion, with concomitant malignant ascites; however, pathologic examination of the pleural and ascitic fluids did not detect EGFR T790Mmutation. Afatinib(2 0mg/day) was started, but there was no decrease in the severity of ascites. Two months later, her condition was extremely deteriorated. Finally, a much larger amount of ascitic fluid obtained by paracentesis was processed for cellblock, which demonstrated EGFR exon 20 T790M mutation. Thereafter, the ascites and the primary lesion dramatically decreased after treatment with osimerti- nib(80mg/day).

Utility of rapid on-site cytologic evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions.

OBJECTIVE: The utility of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions is unclear. The aim of this study was to evaluate the role of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions. METHODS: Consecutive patients who underwent endobronchial ultrasound with a guide sheath for the diagnosis of peripheral pulmonary lesions at our hospital between September 2012 and July 2014 were included in this retrospective study. Cytology slides were air-dried, and modified Giemsa (Diff-Quik) staining was used for rapid on-site evaluation. Additional smears were prepared for Papanicolaou staining and tissue samples were placed in formalin for histologic evaluation. The results of rapid on-site evaluation were compared with the final diagnoses of endobronchial ultrasound with a guide sheath. RESULTS: A total of 718 cases were included in the study population. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of rapid on-site evaluation during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions was 88.6%, 65.9%, 81.2%, 77.7% and 80.1%, respectively. There were no procedure-related deaths. CONCLUSIONS: Rapid on-site evaluation during endobronchial ultrasound with a guide sheath had high sensitivity for peripheral pulmonary lesions. When carrying out rapid on-site evaluation of transbronchial biopsy samples from peripheral pulmonary lesions, careful interpretation and clinical correlation are necessary.

Radial endobronchial ultrasound images for ground-glass opacity pulmonary lesions.

Radial endobronchial ultrasound (R-EBUS) is a useful tool for precise localisation of peripheral pulmonary lesions, but there have been no detailed reports about the use of R-EBUS images for ground-glass opacity (GGO). The R-EBUS images of 116 patients with GGO, who were diagnosed as having adenocarcinoma by R-EBUS with a guide sheath (EBUS-GS), were compared with the respective chest computed tomography findings. In 103 patients, R-EBUS images were correlated with the histological surgical specimens. R-EBUS images of GGO were identified based on the internal structure of the lesion and classified into two groups. Blizzard showed an enlarged, diffuse hyperintense acoustic shadow. Mixed blizzard showed a combination of blizzard and some diffuse heterogeneity with several hyperechoic dots and vessels. All pure GGO lesions (nine out of nine) were blizzard on R-EBUS. For part-solid GGOs, the percentage of mixed blizzard was inversely related to the amount of the GGO component. Histological findings from surgery revealed that all blizzard lesions were on the spectrum of adenocarcinoma in situ to well differentiated adenocarcinoma while majority (33 out of 64) of mixed blizzard lesions were moderately to poorly differentiated adenocarcinoma. R-EBUS types are important to locate GGOs prior to transbronchial sampling with EBUS-GS.

Novel use for an EGFR mutation-specific antibody in discriminating lung adenocarcinoma from reactive pneumocyte hyperplasia.

AIMS: Pulmonary ground-glass nodules (GGNs) are frequently observed. Histopathologically, their presentation can indicate a wide range of disorders from an inflammatory process to malignancy. An accurate diagnosis based on GGNs can sometimes be challenging on small-sized biopsies. Mutations in the EGFR gene are detected in pulmonary adenocarcinomas (ADCs). Immunohistochemical analysis using antibodies that detect specific EGFR mutations has been shown to correlate with mutational status as determined by molecular methods. We hypothesized that these antibodies could be used to discriminate between ADCs and benign pneumocyte hyperplasias. METHODS AND RESULTS: Surgically resected, pre-invasive to invasive lung ADC (n = 32) and reactive pneumocyte hyperplasia (n = 40) tissue samples were probed with antibodies against EGFR mutations, p53, Mouse double minute 2 and 14-3-3 sigma. Of the 32 lung ADC specimens analysed, 12 (38%) were positive using the EGFR mutation-specific antibodies, while no immunoreactivity was observed in reactive pneumocyte hyperplasia specimens. Analyses of receiver operating characteristic curves showed that the highest area under the curve values were associated with the use of EGFR mutation-specific antibodies. In addition, a high concordance rate was observed between surgically resected and corresponding biopsy materials using these antibodies. CONCLUSIONS: EGFR mutation-specific antibodies can be used to discriminate between lung ADC and benign pneumocyte hyperplasia, even in small-sized biopsies.

The diagnostic value of histology and cytology samples during endobronchial ultrasound with a guide sheath.

OBJECTIVE: Endobronchial ultrasound with a guide sheath has been a widely used diagnostic procedure for peripheral pulmonary lesions. After sequential sampling with the usual devices, small portions of the collected specimen remain in the guide sheath and these can potentially contribute to diagnosis. We assessed the diagnostic value of each histological and cytological sample, especially the guide sheath flush, for pulmonary malignancies. METHODS: The medical records of patients who were diagnosed to have peripheral lung cancer by endobronchial ultrasound with a guide sheath in our hospital between January 2014 and May 2014 were reviewed. Separate samples from forceps biopsy, bronchial brushing, device wash, guide sheath flush and bronchial lavage were compared and analyzed. RESULTS: A total of 106 consecutive patients (54 men, 52 women, median age 69.0 years) were included. The median long axis size of the lesions was 26.0 mm. A definitive diagnosis was made in 90.6% of forceps biopsy samples and in 85.8% of all cytology samples combined. Individual yields were 61.3% from brushing, 77.4% from device wash, 72.6% from guide sheath flush and 32.1% from bronchial lavage. The diagnosis yield from forceps biopsy was significantly higher than each cytological sampling method (P < 0.05). Among the cytological sampling methods, yield from bronchial lavage was significantly the lowest (P < 0.001). CONCLUSIONS: Forceps biopsy is an important sampling method during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions. In the collection of diagnostic liquid samples, guide sheath flush is more advantageous than bronchial lavage and provides specimen that may be adequate for molecular testing.

Complications with Endobronchial Ultrasound with a Guide Sheath for the Diagnosis of Peripheral Pulmonary Lesions.

BACKGROUND: Diagnostic bronchoscopy has been considered as a safe and effective procedure. Endobronchial ultrasound with a guide sheath (EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) is becoming a common procedure, but reports about its safety are missing. OBJECTIVES: The aim of this study was to evaluate the safety profile of EBUS-GS for the diagnosis of PPLs. METHODS: All patients with PPLs who underwent EBUS-GS between September 2012 and August 2014 at the National Cancer Center Hospital were included. Postprocedural complications and the durability of devices were retrospectively reviewed. RESULTS: During the study period, EBUS-GS procedures were performed for 965 PPLs. The overall complication rate was 1.3% (13/965): 0.8% (8/965) for pneumothorax and 0.5% (5/965) for pulmonary infection. There was no significant hemorrhage, air embolism, tumor seeding or procedure-related death, and there was no breakage of the guide sheath. Only four radial probes were broken during the study period without any adverse reactions. CONCLUSIONS: EBUS-GS is a tolerable procedure, and the devices are durable.

Comparison of two 22 G aspiration needles for histologic sampling during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).

OBJECTIVE: Endobronchial ultrasound-guided transbronchial needle aspiration is widely used for mediastinal and hilar lesions. Histologic specimens from this procedure are important for specific diagnosis and targeted therapy. Studies on the traditional endobronchial ultrasound-guided transbronchial needle aspiration needles reported yields of only 50-60% for diagnostic histologic specimens. Recently, a new needle has become available in Europe, USA and Asia. The investigators aimed to evaluate the histologic specimen retrieval yields of the two needles. METHODS: Patients who underwent endobronchial ultrasound-guided transbronchial needle aspiration with the new 22 G needle (M group, n = 94) were compared with a historical control group who underwent endobronchial ultrasound-guided transbronchial needle aspiration with the traditional 22 G needle (O group, n = 82). The quality of needle aspirates from both groups was evaluated. RESULTS: There were no significant differences between the two groups in terms of demographics, lesion characteristics, primary disease and examiner experience. The M group had a significantly shorter procedure time than the O group (P = 0.049). Of the 214 punctures by the M group, 159 (74.3%) were diagnostic, 28 (13.1%) were non-diagnostic and 27 (12.6%) had no histologic specimen. The 235 punctures by the O group were diagnostic in 144 (61.3%), non-diagnostic in 60 (25.5%) and had no histologic specimen in 31 (13.2%). The yield for diagnostic histologic specimens of the M group was significantly higher than the O group (P = 0.0035). There were no major complications observed. CONCLUSIONS: The yield for diagnostic histologic specimens by the new 22 G endobronchial ultrasound-guided transbronchial needle aspiration needle was high. Further technical improvements of histologic sampling yields are very important when selecting targeted therapy.

Endobronchial ultrasound elastography in the diagnosis of mediastinal and hilar lymph nodes.

OBJECTIVE: Endobronchial ultrasound elastography is a new technique for describing the stiffness of tissue during endobronchial ultrasound-guided transbronchial needle aspiration. The aims of this study were to evaluate the utility of endobronchial ultrasound elastography for mediastinal and hilar lymph nodes, and to compare the elastographic patterns of lymph nodes with results from endobronchial ultrasound-guided transbronchial needle aspiration. METHODS: Seventy-five lymph nodes were evaluated. A convex probe endobronchial ultrasound was used with a new endoscopic ultrasound processor to assess elastographic patterns that were classified based on color distribution as follows: Type 1, predominantly non-blue (green, yellow and red); Type 2, part blue, part non-blue (green, yellow and red); Type 3, predominantly blue. The elastographic patterns were compared with the final pathologic results from endobronchial ultrasound-guided transbronchial needle aspiration. RESULTS: On pathological evaluation of the lymph nodes, 33 were benign and 42 were malignant. The lymph nodes that were classified as Type 1 on endobronchial ultrasound elastography were benign in 24/24 (100%); for Type 2 lymph nodes, 6/14 (46.9%) were benign and 8/14 (57.1%) were malignant; Type 3 lymph nodes were benign in 2/37 (5.4%) and malignant in 35/37 (94.6%). In classifying Type 1 as 'benign' and Type 3 as 'malignant,' the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy rates were 100, 92.3, 94.6, 100 and 96.7%, respectively. CONCLUSIONS: Endobronchial ultrasound elastography of mediastinal and hilar lymph nodes is a noninvasive technique that can be performed reliably and may be helpful in the prediction of nodal metastasis during endobronchial ultrasound-guided transbronchial needle aspiration.

Flex-rigid pleuroscopy under local anesthesia in patients with dry pleural dissemination on radiography.

OBJECTIVE: Medical thoracoscopy using a flex-rigid pleuroscope under local anesthesia is a recent diagnostic procedure for malignant pleural disease. Although most previous studies have reported its usefulness, especially in wet pleural dissemination, the feasibility of flex-rigid pleuroscopy in patients with dry pleural dissemination is not well established.We assessed the diagnostic performance of flex-rigid pleuroscopy under local anesthesia in patients suspected of dry pleural dissemination on radiography. METHODS: The pleuroscopic parameters of all patients (n = 56) who underwent flex-rigid pleuroscopy at the National Cancer Center Hospital from October 2011 to September 2013 were retrospectively reviewed. Those with computed tomography findings of asymmetric pleural thickening or pleural nodules without pleural effusion (dry group, n = 16) were compared with the remaining patients with pleural effusion (wet group). RESULTS: The dry group consisted of eight men and eight women, with a median age of 61 years (range, 48-79 years). The definitive diagnoses were adenocarcinoma (n = 10), mesothelioma (n = 2) and chronic inflammation (n = 3). The diagnostic accuracy was 93.8% (15/16). Only two minor complications were observed: mild chest pain (n = 1) and transient hypoxia (n = 1). No major complications such as pneumothorax were observed. The mean duration of post-operative chest tube drainage in the dry group was 2.31 ± 2.26 days. Complications, operation duration and diagnostic accuracy did not statistically differ between the two groups. CONCLUSIONS: Flex-rigid pleuroscopy under local anesthesia can be a well-tolerated diagnostic procedure for radiographic dry pleural dissemination with respect to diagnostic yield and complications.

A new middle-range diameter bronchoscope with large channel for transbronchial sampling of peripheral pulmonary lesions.

OBJECTIVE: Although the diagnostic yield of guided bronchoscopy for peripheral pulmonary lesions has improved to 70%, it is still low compared with transthoracic needle aspiration. We produced a new bronchoscope with middle-range diameter and large channel (BF-Y0053, Olympus, Japan), and evaluated its diagnostic efficacy for peripheral pulmonary lesions. METHODS: This was a retrospective study on 70 consecutive patients with peripheral pulmonary lesions who underwent diagnostic bronchoscopy using BF-Y0053 combined with endobronchial ultrasound with a guide sheath at the National Cancer Center Hospital from September 2013 to November 2013. Diagnostic performance of the procedure was analyzed and compared among three groups of peripheral pulmonary lesions: 'peripheral-small' lesions (≤ 30 mm and adjacent to visceral pleura), 'central-small' lesions (≤ 30 mm and not adjacent to the visceral pleura), and 'large' lesions (>30 mm). RESULTS: Sixty (85.7%) patients had malignant diseases. Diagnosis was established by bronchoscopy in 61 of 70 patients (87.1%); the respective yields for 'central-small' and 'large' lesions were significantly higher than that for 'peripheral-small' lesions (96.3%, 94.4%, 72%, P = 0.0026). This diagnostic accuracy was achieved regardless of other clinical and procedural factors such as, lesion size, feature ground glass opacity (or solid), endobronchial ultrasound-probe location (within or outside) or operator skill. There were no major post-procedural complications. CONCLUSIONS: A new middle-range diameter bronchoscope with large channel combined with endobronchial ultrasound with a guide sheath can enhance the efficacy of transbronchial sampling to its maximal potential to diagnose peripheral pulmonary lesions safely and accurately, particularly for patients who have tumors away from the visceral pleura.

The dose and risk factors for radiation exposure to medical staff during endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions under X-ray fluoroscopy.

OBJECTIVE: Therapy for lung cancer has recently evolved to include molecular targeted therapy and adequate amounts of lung cancer tissue are needed to identify particular phenotypes. For this purpose, quite a number of investigations on diagnostic bronchoscopy have been undertaken. Corollary to the increasing number of transbronchial biopsies for peripheral pulmonary nodules is the increased chances of radiation exposure during fluoroscopy. Our aim was to determine the dose and risk factors of radiation exposure to medical staff. METHODS: Endobronchial ultrasonography with a guide sheath under X-ray fluoroscopy was performed on 132 cases of peripheral pulmonary lesions. The radiation exposure dose to medical staff (operator physicians, assistant physicians, nurses and radiological technologists) was measured. RESULTS: The median time of fluoroscopy was 7.6 min (range 1.5-23.9). The median radiation exposure dose to operator physicians was 12 µSv/exam (range 1-99), while that of the other medical staff was lower. In a multivariate analysis, body mass index and the location of the radial ultrasound probe had significantly higher odds ratios. CONCLUSIONS: The risk factors for an increased radiation exposure dose were patients' BMI and the location of the radial ultrasound probe. But even then, the radiation exposure dose to medical staff during endobronchial ultrasonography with a guide sheath was very low, especially for nurses and radiological technologists in whom the exposure dose was negligible.

Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy.

BACKGROUND: With the recent widespread use of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), there have been occasional reports on complications associated with its use. Previous reviews on EBUS-TBNA have been limited to studies by skilled operators, thus the results may not always be applicable to recent clinical practice. To assess the safety of EBUS-TBNA for the staging and diagnosis of lung cancer in Japan, a nationwide survey on its current usage status and complications associated with its use was conducted by the Japan Society for Respiratory Endoscopy (JSRE). METHODS: A questionnaire about EBUS-TBNA performed between January 2011 and June 2012 was mailed to 520 JSRE-accredited facilities. RESULTS: Responses were obtained from 455 facilities (87.5%). During the study period, EBUS-TBNA was performed in 7,345 cases in 210 facilities (46.2%) using a convex probe ultrasound bronchoscope, for 6,836 mediastinal and hilar lesions and 275 lung parenchymal lesions. Ninety complications occurred in 32 facilities. The complication rate was 1.23% (95% confidence interval, 0.97%-1.48%), with hemorrhage being the most frequent complication (50 cases, 0.68%). Infectious complications developed in 14 cases (0.19%) (Mediastinitis, 7; pneumonia, 4; pericarditis, 1; cyst infection, 1; and sepsis, 1). Pneumothorax developed in 2 cases (0.03%), one of which required tube drainage. Regarding the outcome of the cases with complications, prolonged hospitalization was observed in 14 cases, life-threatening conditions in 4, and death in 1 (severe cerebral infarction) (mortality rate, 0.01%). Breakage of the ultrasound bronchoscope occurred in 98 cases (1.33%) in 67 facilities (31.9%), and that of the puncture needle in 15 cases (0.20%) in 8 facilities (3.8%). CONCLUSIONS: Although the complication rate associated with EBUS-TBNA was found to be low, severe complications, including infectious complications, were observed, and the incidence of device breakage was high. Since the use of EBUS-TBNA is rapidly expanding in Japan, an educational program for its safe performance should be immediately established.

Bronchoscopic practice in Japan: a survey by the Japan Society for Respiratory Endoscopy in 2010.

BACKGROUND AND OBJECTIVE: To ensure the safety of bronchoscopic practice, the Japan Society for Respiratory Endoscopy conducted a national survey to investigate the current state of procedure for this technique. METHODS: A questionnaire survey about procedures carried out during the whole of the year 2010 was mailed to 538 facilities accredited by the society. RESULTS: Responses were obtained from 511 facilities (95.0%). Rigid bronchoscopes were used in only 18.5% of the facilities, while mobile/thin bronchoscopes were used in ≥ 50%, and fluoroscopy systems were used in 99.8%. Biopsies were performed after discontinuation of therapy in patients receiving antiplatelet drugs and anticoagulants in 96.7% and 97.4% of the facilities, respectively. Atropine was administered for premedication in 67.5% of the facilities, a decrease from previous surveys. Intravenous sedation was given in 36.1% of the facilities. In 21.9% of these, the procedure was conducted in the outpatient clinic for ≥ 70% of patients. A bronchoscope was orally inserted in ≥ 70% of patients in 95.7% of the facilities. Intravenous access was maintained during the examination in 92.5% of the facilities, oxygen saturation was monitored during examinations in 99.0%, oxygen was administered in 97.6% and resuscitation equipment was available in 96%. In 98.6% of the facilities, bronchoscopes were disinfected using an automatic washing machine, with glutaraldehyde used in 42.2%. CONCLUSIONS: Japan-specific characteristics of bronchoscopic practice were identified. Whether procedures used in Japan meet international guidelines with respect to safety should be monitored continuously. In addition, a Japanese evidence-based consensus is needed.