Diagnosis of Pleural Mesothelioma: Is Everything Solved at the Present Time?

Ranked high in worldwide growing health issues, pleural diseases affect approximately one million people globally per year and are often correlated with a poor prognosis. Among these pleural diseases, malignant pleural mesothelioma (PM), a neoplastic disease mainly due to asbestos exposure, still remains a diagnostic challenge. Timely diagnosis is imperative to define the most suitable therapeutic approach for the patient, but the choice of diagnostic modalities depends on operator experience and local facilities while bearing in mind the yield of each diagnostic procedure. Since the analysis of pleural fluid cytology is not sufficient in differentiating historical features in PM, histopathological and morphological features obtained via tissue biopsies are fundamental. The quality of biopsy samples is crucial and often requires highly qualified expertise. Since adequate tissue biopsy is essential, medical or video-assisted thoracoscopy (MT or VATS) is proposed as the most suitable approach, with the former being a physician-led procedure. Indeed, MT is the diagnostic gold standard for malignant pleural pathologies. Moreover, this medical or surgical approach can allow diagnostic and therapeutic procedures: it provides the possibility of video-assisted biopsies, the drainage of high volumes of pleural fluid and the administration of sterile calibrated talcum powder under visual control in order to achieve pleurodesis, placement of indwelling pleural catheters if required and in a near future potential intrapleural therapy. In this context, dedicated diagnostic pathways remain a crucial need, especially to quickly and properly diagnose PM. Lastly, the interdisciplinary approach and multidisciplinary collaboration should always be implemented in order to direct the patient to the best customised diagnostic and therapeutic pathway. At the present time, the diagnosis of PM remains an unsolved problem despite MDT (multidisciplinary team) meetings, mainly because of the lack of standardised diagnostic work-up. This review aims to provide an overview of diagnostic procedures in order to propose a clear strategy.

Sago-grain nodules in tubercular pleural effusion.

A 6-year-old boy was referred with complaints of chest pain for 2 months with low-grade fever. A computerized tomography of the chest revealed a loculated pleural effusion on the left side. Medical thoracoscopy was performed that revealed a characteristic sago-grain follicle over the parietal pleural. Histopathology and microbiological investigations on pleural biopsy samples confirmed tubercular pleural effusion.

Local Anesthetic Thoracoscopy: A Focus on Indications, Techniques and Complications.

The main purpose of this narrative review is to educate general practitioners about a crucial pleural procedure, namely local anesthetic thoracoscopy (LAT), and to provide established respiratory physicians with an expert opinion-based summary of the literature. This narrative review focuses on the indications, technical aspects and complications of LAT, highlighting its safety and high degree of diagnostic sensitivity for patients who present with an unexplained pleural effusion and have a high pre-test probability of cancer.

Safety and Diagnostic Yield of Medical Pleuroscopy (MP) Performed under Balanced Analgosedation by a Pneumological Team Compared to Video-Assisted Thoracic Surgery (VATS): A Retrospective Controlled Real-Life Study (TORAPO).

INTRODUCTION: Medical pleuroscopy (MP) is an invasive technique that provides access to the pleural space with a rigid or semi-rigid work instrument, allowing for visualization and the obtaining of bioptic pleural samples. Using pulmonologist-based analgosedation to perform pleuroscopy is still debated for safety reasons. The aim of this real-life study is to demonstrate the safety and diagnostic yield of MP performed under balanced analgosedation by a pulmonologist team with expertise in the management of critically ill patients in the respiratory intensive care unit (RICU) and interventional pulmonology unit as compared to video-assisted thoracic surgery (VATS) performed by a thoracic surgeon team under anesthesiologist-based analgosedation. METHODS: In this multicentric retrospective controlled study, the inclusion criteria were patients older than 18 years old with pleural effusion of unknown diagnosis consecutively admitted in the years 2017-2022 to the pulmonology unit and RICU of San Donato Hospital in Arezzo (Italy, Tuscany) and to the thoracic surgery unit of Santa Maria Le Scotte in Siena (Italy, Tuscany) to undergo, respectively, MP under balanced propofol-based analgosedation on spontaneous breathing with local anesthesia provided by a pulmonologist team (Group A), and VATS provided by a surgeon team under propofol-based analgosedation managed by an anesthesiologist using invasive mechanical ventilation (IMV) via endotracheal intubation (ETI) (Group B). The primary endpoints were (1) a comparison between the two groups in terms of the diagnostic yield of pleural effusion, and (2) major and minor complications of pleuroscopic procedures. The secondary endpoints were (1) the length of the pleuroscopic procedure; (2) the duration of hospitalization; (3) propofol doses; and (4) the patient's comfort after the procedure assessed using the Visual Analogue Scale (VAS). RESULTS: We enrolled 91 patients in Group A and 116 patients in Group B. A conclusive diagnosis was obtained in 97.8% of Group A vs. 100% of Group B (p = 0.374). Malignant effusion was diagnosed in 59.3% of Group A and in 55.1% of Group B; p = 0.547. No intraoperative or postoperative mortality events or major complications were observed in Group A. The major complications observed in Group B were three major bleeding events (p = 0.079) and one exitus (p = 0.315) not related to the interventional procedure. No significant difference emerged between the two groups in terms of minor complications. The duration of the intervention was significantly lower in Group A (40.0 min ± 12.6 versus 51.5 ± 31.0; p = 0.001). Pain control and, therefore, patient comfort were better in Group A, with an average VAS of 0.34 ± 0.65 versus 2.58 ± 1.26, p < 0.001. The duration of hospitalization was lower in Group B (5.1 ± 2.6 vs. 15.5 ± 8.0, p < 0.001). The average overall dose of propofol administered was significantly lower in Group A (65.6 ± 35.8 mg versus 280 ± 20.0 mg; p < 0.001). CONCLUSIONS: This real-life study shows that the MP performed under propofol-based analgosedation by an independent pneumologist team is a safe and well-tolerated procedure with a diagnostic yield and complication rates similar to those obtained with VATS.

Evaluating the safety of intraprocedural chest tube removal during medical thoracoscopy.

BACKGROUND: Medical Thoracoscopy (MT) is a diagnostic procedure during which after accessing the pleural space the patient's negative-pressure inspiratory efforts draw atmospheric air into the pleural cavity, which creates a space to work in. At the end of the procedure this air must be evacuated via a chest tube, which is typically removed in the post-anesthesia care unit (PACU). We hypothesized that its removal intra-operatively is safe and may lead to lesser post-operative pain in comparison to its removal in the PACU. METHODS: A retrospective review was conducted of all the MT with intraprocedural chest tube removal done between 2019 to 2023 in adult patients in a single center in New York, NY by interventional pulmonology. RESULTS: A total of 100 MT cases were identified in which the chest tube was removed intra-operatively. Seventy-seven percent of cases were performed as outpatient and all these patients were discharged on the same day. Post procedure ex-vacuo pneumothorax was present in 42% of cases. Sixty-five percent of cases had some post-procedure subcutaneous emphysema, none reported any complaint of this being painful, and no intervention was needed to relieve the air. Seventy-three percent required no additional analgesia in PACU. Of the 27% that required any form of analgesia, 59% required no additional analgesia beyond the first 24 h. CONCLUSIONS: Intraprocedural CT removal for MT is safe and may decrease utilization of additional analgesia post procedure. Further prospective studies are necessary to validate these conclusions.

Anesthetic considerations for medical pleuroscopy.

Pleuroscopy, also known as medical thoracoscopy or local anesthesia thoracoscopy, is a commonly utilized procedure in the growing field of interventional pulmonology and considered a required procedure as part of the interventional pulmonology fellowship curriculum. Pleuroscopy is mainly utilized for parietal pleural biopsies in patients with undiagnosed pleural effusions, with a comparable diagnostic yield to video-assisted thoracoscopy (VATS) (>92%). Pleuroscopy is also performed for talc insufflation for pleurodesis, indwelling pleural catheter insertion, and rarely for decortication in patients with stage 2 empyema. Though these procedures can be done under local anesthesia with moderate sedation, an increasing number of cases are being performed with the presence of the anesthesiologist providing monitored anesthesia care (MAC). Given that a significant number of patients undergoing pleuroscopy will have significant co-morbidities, proceduralists and anesthesiologists must be prepared to manage these cases in a non-OR setup. In this article, we discuss some of the technical aspects of pleuroscopy, and highlight the peri-operative considerations for proceduralists and anesthesiologists in managing these patients including the role of ultrashort sedatives and intraoperative procedural and anesthetic considerations. We also discuss the upcoming adjunctive role of local and regional anesthesia techniques in management of these patients. In addition, we summarize the current data regarding various regional anesthesia techniques and discuss avenues for further research.

Establishing a Multidisciplinary Team-Based Pleural Service in the Era of Financial Austerity: The Role of the Thoracic Surgeon.

Medical thoracoscopy/pleuroscopy has become, after bronchoscopy, the second most commonly utilized endoscopic procedure in interventional pulmonology. Due to their common origin, medical thoracoscopy/pleuroscopy and video-assisted thoracic surgery (VATS) are quite similar procedures technically. In contrast to the prevailing attitude that it should predominantly be performed by interventional pulmonologists, we believe that, like all hybrid-in-nature techniques, it should be implemented as part of a combined specialist care service/team. Herewith, we describe our attempt to establish a multidisciplinary pleural disease program during a difficult economic period for our country, comprising thoracic surgeons, pulmonologists and anesthesiologists, all of whom brought in their experience, expertise and resources to establish and develop the service resulting in a hybridization of the technique, with, as reported, quite favorable results.

Medical Thoracoscopy and Intrapleural Fibrinolytic Therapy for the Management of Pleural Empyema: A Cohort Study.

BACKGROUND: Pleural empyema is associated with relevant morbidity and mortality, and it may be classified, according to evolution and ultrasound, into three stages: stage I (free-flowing effusion), stage II (viscous effusion with the tendency to loculate), and stage III (organizing phase). According to guidelines, antibiotic therapy and pleural drainage are recommended, with surgery being performed when patients fail and/or in case of organized empyema. OBJECTIVES: The aim of the study was to report the efficacy and safety of medical thoracoscopy in patients with pleural empyema stratified by chest ultrasound. METHOD: Observational retrospective cohort study analyzing patients with pleural empyema treated with medical thoracoscopy. Procedure success and mortality were evaluated at 30 days and 90 days after the procedure; complications were also reported. RESULTS: 131 patients were included. Intrapleural fibrinolytic therapy was performed thereafter in the majority of cases. Medical thoracoscopy was considered successful without subsequent intervention in 99 patients (76%); 19 patients (15%) underwent a second procedure (drainage, thoracoscopy, video-assisted thoracic surgery, or thoracotomy); and 6 patients (5%) died of the evolution of empyema. Patients treated in stages I and II showed significantly better post-procedure results compared with patients treated in stage III (100%, 83.3%, and 58.1%, respectively). Thoracoscopy complications were observed in 18 patients and were reversible in all cases. CONCLUSIONS: Patients with pleural empyema treated in earlier stages (free-flowing or multiloculated effusion) with medical thoracoscopy show significantly better results than patients treated in later stages (organized empyema). This approach is safe, minimally invasive, and efficient in these patients with disease having relevant mortality; however, patient selection remains essential.

Parietal Pleural Lymphatic Blockage by Anthracotic Nodule Laden Macrophage, Leading Cause of Pleural Effusion in Anthracosis.

Anthracosis of lung is assumed to be a disease that causes parenchymal accumulation of macrophage-laden anthracotic nodules, which leads to bronchial obstruction, lung mass, and lymphadenopathy. Pleural surface anthracosis involvement as extra-parenchymal involvement has been rarely reported. Still, due to presentation with a transudate pattern, pleural effusion is considered to be a side effect of lung collapse. I represent two subjects with patches of anthracosis in the presumptive place of anatomical fenestra of lymphatic vessels in the parietal pleural. It may cause inhibition of reabsorption of pleural fluid and finally accumulation of transudate pleural effusion. Involvement of the pleura by anthracosis, and black discoloration of the parietal pleura have already been discovered by physicians who perform pleuroscopy. The pleural involvement by anthracosis is usually diffuse. In these two subjects, pleural involvement was in the early stage of anthracosis, which helped me to introduce a new mechanism for transudative pleural effusion due to blockage of the pleural lymphatic channels entrance.

Malignant pleural effusion: Updates in diagnosis, management and current challenges.

Malignant pleural effusion (MPE) is a common condition which often causes significant symptoms to patients and costs to healthcare systems. Over the past decade, the management of MPE has progressed enormously with large scale, randomised trials answering key questions regarding optimal diagnostic strategies and effective management strategies. Despite a number of management options, including talc pleurodesis, indwelling pleural catheters and combinations of the two, treatment for MPE remains symptom directed and centered around drainage strategy. The future goals for providing improved care for patients lies in changing the treatment paradigm from a generic pathway to personalised care, based on probability of malignancy type and survival. This article reviews the current evidence base, new discoveries and future directions in the diagnosis and management of MPE.

Use of tunneled pleural catheters in chronic empyema: Two case reports and brief review of the literature.

The incidence of empyema is increasing worldwide, which, coupled with the aging global population, makes the non-surgical management of pleural space infections increasingly important. Despite this, there remains no consensus for management of chronic empyema in those patients who are not surgical candidates and do not get adequate source control with chest tube and intra-pleural lytic therapy, particularly for patients with non-expandable lungs. We reviewed the literature regarding non-surgical management of chronic empyema and present two cases that support the use of pleuroscopy in conjunction with tunneled pleural catheters for management of chronic empyema in non-surgical candidates.

Efficacy and Safety of Pleural Cryobiopsy vs. Forceps Biopsy for Evaluation of Undiagnosed Pleural Effusion: A Systematic Review and Meta-Analysis.

Background: Pleural cryobiopsy is a novel technique for the diagnosis of pleural pathologies. However, the safety and feasibility of this modality compared to standard forceps for pleural biopsy has not been fully elucidated. This systematic review and meta-analysis aims to establish the efficacy and safety of cryobiopsy for evaluation of undiagnosed pleural effusion. Methods: For this systematic review and meta-analysis, we searched PubMed, Embase, Scopus, and Web of science databases up to December 16, 2021 to identify relevant articles. We included randomized controlled trials, cohort studies, retrospectives studies and case series that compared pleural cryobiopsy and forceps biopsy. A qualitative assessment was performed using the QUADAS-2 tool. Results: Of the 365 articles identified by our search, 15 studies were eligible for inclusion. The specimen sizes obtained with cryobiopsy were significantly larger compared with forceps biopsy (Standard mean difference 1.16; 95 % CI: 0.51-1.82; P < 0.01). Furthermore, the cryobiopsy tissue specimens were deeper (OR 2.68; 95 % CI: 1.39-5.16; P < 0.01) and qualitatively better with less crush artifacts (OR 0.06; 95 % CI: 0.01-0.26; P < 0.01). There was no significant difference in diagnostic yield (OR 1.32; 95 % CI: 0.79-2.21; P = 0.29) and mild to moderate bleeding events (OR 1.21; 95 % CI: 0.64-2.29; P = 0.57) between pleural cryobiopsy and forceps biopsy. No publication bias was observed among these studies. Conclusions: Compared to flexible forceps biopsy pleural cryobiopsy obtained larger and deeper tissue specimens with less crush artifacts but does not show superiority for diagnostic yield. Further studies are still needed to verify these findings.

Update on the diagnosis and management of malignant pleural effusions.

Roughly 150,000 malignant pleural effusions (MPE) are diagnosed in the United States each year. The majority of cases are caused by lung and breast cancer, and since MPE represents advanced disease, the prognosis is generally poor. In this article we review the pathophysiology, epidemiology, and prognosis of MPE. We then discuss the approach to diagnosis of MPE including the role of imaging, pleural fluid analysis, and medical thoracoscopy. Current management strategies for symptomatic MPE include repeated thoracentesis for patients with very limited life expectancy as well as more definitive procedures such as chemical pleurodesis, tunneled indwelling pleural catheters, and novel combined approaches. The choice of intervention is guided by the efficacy, local expertise, and risk, as well as patient factors and preferences.

Predicting malignant pleural effusion during diagnostic pleuroscopy with biopsy: A prospective multicentre study.

BACKGROUND AND OBJECTIVE: Pleuroscopy with pleural biopsy has a high sensitivity for malignant pleural effusion (MPE). Because MPEs tend to recur, concurrent diagnosis and treatment of MPE during pleuroscopy is desired. However, proceeding directly to treatment at the time of pleuroscopy requires confidence in the on-site diagnosis. The study's primary objective was to create a predictive model to estimate the probability of MPE during pleuroscopy. METHODS: A prospective observational multicentre cohort study of consecutive patients undergoing pleuroscopy was conducted. We used a logistic regression model to evaluate the probability of MPE with relation to visual assessment, rapid on-site evaluation (ROSE) of touch preparation and presence of pleural nodules/masses on computed tomography (CT). To assess the model's prediction accuracy, a bootstrapped training/testing approach was utilized to estimate the cross-validated area under the receiver operating characteristic curve. RESULTS: Of the 201 patients included in the study, 103 had MPE. Logistic regression showed that higher level of malignancy on visual assessment is associated with higher odds of MPE (OR = 34.68, 95% CI = 9.17-131.14, p < 0.001). The logistic regression also showed that higher level of malignancy on ROSE of touch preparation is associated with higher odds of MPE (OR = 11.63, 95% CI = 3.85-35.16, p < 0.001). Presence of pleural nodules/masses on CT is associated with higher odds of MPE (OR = 6.61, 95% CI = 1.97-22.1, p = 0.002). A multivariable logistic regression model of final pathologic status with relation to visual assessment, ROSE of touch preparation and presence of pleural nodules/masses on CT had a cross-validated AUC of 0.94 (95% CI = 0.91-0.97). CONCLUSION: A prediction model using visual assessment, ROSE of touch preparation and CT scan findings demonstrated excellent predictive accuracy for MPE. Further validation studies are needed to confirm our findings.

Evolution of semi-rigid thoracoscopy.

Pleural effusions despite being so common, there is no much literature available regarding definite diagnosis for pleural effusions. Application of Light's criteria changed the approach to pleural effusion and till date remains a very useful step in the diagnosis of pleural effusions. Pleural fluid biochemistry and adenosine deaminase (ADA) enzyme levels play a significant role in the diagnosis of tubercular effusion. Studies have shown that levels of ADA are more often higher in tubercular effusion than in any other cause for it. But ADA levels can also be elevated in other types of parapneumonic effusions (PPEs), especially complicated PPEs. Hence it is difficult to distinguish a tubercular pleural effusion (TPE) from other PPEs based on pleural fluid ADA levels alone. LDH/ADA ratio as an indicator for ruling out tuberculosis was analyzed in few studies with high sensitivity and specificity. The pleural fluid cytology has a varying sensitivity, with a maximum of only 60% and it may increase with subsequent tapping. Closed pleural biopsy using a Cope or Abrams needle has a sensitivity up to 80% in cases of tuberculous effusion and 40%-73% in cases of Malignancies. Semi-rigid thoracoscopy not only allows for visualization of the pleura but also helps in procuring the biopsies under direct visualization from the abnormal looking areas. In cases of primary pleural malignancies like mesothelioma, pleurodesis can also be done in the same setting after taking the biopsy, hence reducing the number of procedures. Limitation of the semi-rigid thoracoscopy is smaller sample size and more superficial sampling of the pleura. Cryobiopsy and Electrocautery guided pleural biopsy using the IT knife are the modifications in the semi-rigid thoracoscopy to overcome the drawback of smaller sample size. While navigation band image guided pleuroscopy helps in better visualization of the vasculature of pleura during the biopsy. Management of pleural effusions has evolved over a period of time. Starting with a single criterion based on pleural fluid proteins to semi-rigid thoracoscopy. The inexhaustible research in this field suggests the desperate need for a gold standard procedure with cost effectiveness in the management of undiagnosed pleural effusions. Semi-rigid thoracoscopy has revolutionized the management of undiagnosed pleural effusions, but it has its own limitations. Various modifications have been proposed and tried to overcome the limitations to make it a cost-effective procedure.

Review of the Physiology and Anesthetic Considerations for Pleuroscopy/Medical Thoracoscopy.

Pleuroscopy or medical thoracoscopy is the second most common utilized procedure after bronchoscopy in the promising field of interventional pulmonology. Its main application is for the diagnosis and management of benign or malignant pleural effusions. Entry into the hemithorax is associated with pain and patient discomfort, whereas concurrently, notable pathophysiologic alterations occur. Therefore, frequently procedural sedation and analgesia is needed, not only to alleviate the patient's emotional stress and discomfort by mitigating the anxiety and minimizing the pain but also for yielding better procedural conditions for the operator. The scope of this review is to present the physiologic derangements occurring in pleuroscopy and compare the various anesthetic techniques and sedative agents that are currently being used in this context.

Medical Thoracoscopy.

Medical thoracoscopy is an effective and safe modality to visualize and sample contents of the pleural cavity. It is an outpatient procedure that can be performed while the patient is spontaneously breathing, with the use of local anesthesia and intravenous medications for sedation and analgesia. Medical thoracoscopy has indications in the management of a variety of pleural diseases. It is most commonly performed as a diagnostic procedure but has therapeutic applications as well. Although it has its advantages, management strategies of certain pleural diseases should take place within a multidisciplinary environment including general pulmonologists, interventional pulmonologists, and thoracic surgeons.

Diagnosis of tuberculous pleural effusions: A review.

Tuberculous pleural effusion (TPE) is the second most common presentation of extrapulmonary tuberculosis. The paucibacillary nature of the effusion poses diagnostic challenges. Biomarkers like adenosine deaminase and interferon-γ have some utility for diagnosing TPEs, as do cartridge-based polymerase chain reaction (PCR) methods. When these fluid studies remain indeterminate, pleural biopsies must be performed to confirm the diagnosis. This review article elaborates on the scientific evidence available for various diagnostic tests and presents a practical approach to the diagnosis of TPEs.

Monitored Anesthesia Care with Dexmedetomidine Supplemented by Midazolam/Fentanyl versus Midazolam/Fentanyl Alone in Patients Undergoing Pleuroscopy: Effect on Oxygenation and Respiratory Function.

Although pleuroscopy is considered a safe and well tolerated procedure with a low complication rate, it requires the administration of procedural sedation and analgesia. The purpose of this study was to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic pleuroscopy. Through a prospective, single center, cohort study, we studied 55 patients receiving either a dexmedetomidine intravenous infusion supplemented by midazolam/fentanyl (Group DEX + MZ/F) or a conventional sedation protocol with midazolam/fentanyl (Group MZ/F). Our primary outcome was the changes in lung gas exchange (PaO2/FiO2 ratio) obtained at baseline and at predetermined end points, while changes in respiratory mechanics (FEV1, FVC and the ratio FEV1/FVC) and PaCO2 levels, drug consumption, time to recover from sedation and adverse events were our secondary endpoints (NCT03597828). We found a lower postoperative decrease in FEV1 volumes in Group DEX + MZ/F compared to Group MZ/F (p = 0.039), while FVC, FEV1/FVC and gas exchange values did not differ between groups. We also found a significant reduction in midazolam (p < 0.001) and fentanyl consumption (p < 0.001), along with a more rapid recovery of alertness postprocedure in Group DEX + MZ/F compared to Group MZ/F (p = 0.003), while pain scores during the postoperative period, favored the Group DEX + MZ/F (p = 0.020). In conclusion, the use of intravenous dexmedetomidine during pleuroscopy is associated with a smaller decrease in FEV1, reduction of the consumption of supplementary sedatives and analgesics and quicker awakening of patients postoperatively, when compared to midazolam/fentanyl. Therefore, dexmedetomidine administration may provide clinically significant benefits in terms of lung mechanics and faster recovery of patients undergoing pleuroscopy.

Assessment of competence in local anaesthetic thoracoscopy: development and validity investigation of a new assessment tool.

BACKGROUND: The aims of the study were to develop an assessment tool in local anaesthetic thoracoscopy (LAT), investigate validity evidence, and establish a pass/fail standard. METHODS: Validity evidence for the assessment tool was gathered using the unified Messick framework. The tool was developed by five experts in respiratory medicine and medical education. Doctors with varying experience performed two consecutive procedures in a standardized, simulation-based setting using a newly developed thorax/lung silicone model. Performances were video-recorded and assessed by four expert raters using the new tool. Contrasting groups' method was used to set a pass/fail standard. RESULTS: Nine novices and 8 experienced participants were included, generating 34 recorded performances and 136 expert assessments. The tool had a high internal consistency (Cronbach's alpha =0.94) and high inter-rater reliability (Cronbach's alpha =0.91). The total item score significantly correlated with the global score (rs=0.86, P<0.001). Participants' first performance correlated to second performance (test-retest reliability) with a Pearson's r of 0.93, P<0.001. Generalisability (G) study showed a G-coefficient of 0.92 and decision (D) study estimated that one performance assessed by two raters or four performances assessed by one rater are needed to reach an acceptable reliability, i.e., G-coefficient >0.80. The tool was able to discriminate between the two groups in both performances: experienced mean score =30.8±4.2; novice mean score =15.8±2.3, P<0.001. Pass/fail standard was set at 22 points. CONCLUSIONS: The newly developed assessment tool showed solid evidence of validity and can be used to ensure competence in LAT.