The impact of anesthesia methods and rapid on-site evaluation on the diagnosis of lung cancer using endobronchial ultrasound-guided transbronchial needle aspiration: a retrospective study

Introduction

Lung cancer stands as one of the most prevalent and lethal malignancies (1,2). Presently, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has emerged as a critical tool in lung cancer assessment, demonstrating high sensitivity and specificity in both diagnosis and staging (3,4). EBUS-TBNA procedures are commonly performed under local anesthesia with conscious sedation. A study has suggested that performing EBUS-TBNA under general anesthesia may increase lymph node sample and enhance diagnostic yield (5). However, research also indicates that whether EBUS-TBNA is conducted under conscious sedation or general anesthesia, there appears to be no significant difference in diagnostic efficacy, complications, or patient tolerance (6,7). Currently, no guidelines or high-quality studies advocate absolute superiority of either anesthetic approach.

The application of rapid on-site evaluation (ROSE) in interventional pulmonology began in the 1980s. Pak et al. (8) conducted bedside rapid staining of 37 percutaneous chest needle biopsy specimens, completing the process within 5 minutes and providing results interpretation within 15 minutes, allowing patients to determine specimen adequacy before leaving the operating room. With the widespread adoption of EBUS-TBNA, higher demands have been placed on the diagnostic success rate of puncture samples. Interventional diagnosis is evolving towards precision and minimally invasive (9,10), and the rapid and efficient characteristics of ROSE have elevated its status in the interventional diagnostic field. Several studies have shown that combining ROSE with EBUS-TBNA can improve diagnostic efficacy (11-13), reduce the number of puncture needles (14,15), and decrease complications (16). However, some studies have taken a skeptical stance on whether ROSE can enhance diagnostic or staging efficacy (15,17).

In summary, there is still controversy regarding whether the choice of anesthesia method during EBUS-TBNA and the use of ROSE can improve the diagnostic efficacy of lung cancer. The impact of combining general anesthesia with ROSE on diagnosing lung cancer and whether it can further enhance diagnostic efficacy beyond traditional methods or single factors remain unknown. Therefore, this study investigates on the value of the aforementioned factors in diagnosing lung cancer through EBUS-TBNA. This manuscript is written in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1117/rc).

Methods

Study population

This study collected data from patients who underwent EBUS-TBNA at the Department of Respiratory and Critical Care Medicine, The Affiliated Hospital of Southwest Medical University, from August 2018 to December 2023. Inclusion criteria were as follows: patients who underwent chest computed tomography (CT) scans, either plain or enhanced, prior to the procedure, showing pulmonary lesions with or without mediastinal and hilar lymph node enlargement, with clinical suspicion of malignant lung tumors. Patients with incomplete medical records or without a definitive final diagnosis were excluded. Basic information such as age, sex, smoking history, as well as details regarding lesions and lymph nodes, puncture procedures, pathological results, and final diagnosis were collected from the electronic medical record system. According to the above criteria, patients were divided into three groups based on whether they underwent general anesthesia and ROSE: non-general anesthesia group (NGA group), general anesthesia group (GA group), and general anesthesia with ROSE group (RGA group). The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013) and approved by the Ethics Committee of The Affiliated Hospital of Southwest Medical University (No. KY2023314), and individual consent for this retrospective analysis was waived.

Anesthetic procedure

The NGA group received nebulized lidocaine for oropharyngeal anesthesia and intravenous analgesic and sedative drugs, consisting of a combination of fentanyl and midazolam. Spontaneous respiration was maintained during the procedure. The endobronchial ultrasound bronchoscope was inserted nasally into the airway, and additional medication was administered intraoperatively based on the patient’s condition.

The GA group and the RGA group received general anesthesia, resulting in loss of consciousness and unresponsiveness to painful stimuli, with no spontaneous respiration. After anesthesia induction, a laryngeal mask airway was inserted, and ventilation was controlled by the anesthesia machine. The endobronchial ultrasound bronchoscope was inserted through the laryngeal mask airway into the airway. Medications that may be used intraoperatively include propofol, fentanyl, ketamine, sufentanil, etomidate, and rocuronium.

EBUS-TBNA and ROSE

All patients underwent routine bronchoscopy (Olympus BF-260, Tokyo, Japan) to observe the airway condition initially, followed by switching to endobronchial ultrasound bronchoscopy (Olympus UC-260-FW, with the ultrasound processor Olympus EU-ME1, Tokyo, Japan) for EBUS-TBNA. Physiological saline was used to inflate the water bladder of the ultrasound probe. The probe was inserted into areas indicated by chest CT scans where lung lesions or abnormal enlargement of mediastinal or hilar lymph nodes were present. The probe was adjusted to the maximum short axis diameter of the lesion or lymph node. Color Doppler was utilized to assess the blood supply within and around the lesion, measure the lesion size, avoid blood vessels, select appropriate puncture points, and insert the puncture needle (Olympus NA-201SX-4021, 21G, Tokyo, Japan) through the working channel and fix it onto the endobronchial ultrasound bronchoscope. The outer sheath was adjusted, and after confirming the puncture site, the needle was inserted into the lesion. After removing the needle core, a negative pressure suction device was connected, and aspiration was performed 20–30 times. After completing the puncture, the puncture specimens were processed.

Tissue samples obtained from both the NGA group and the GA group were fixed in formalin and sent for pathological examination. Pathologists examined and decided whether immunohistochemistry was necessary based on the sample condition. Additionally, cytological smears obtained from the puncture were fixed in 95% ethanol for cytological pathological examination. In the RGA group, cytologists performed on-site preparation of smears after each puncture. Rapid staining using the Diff-Quik method was conducted, and quick on-site evaluation was performed based on cytological results under the microscope. If the results suggested a clear qualitative diagnosis (such as the presence of cancer cells) or the presence of numerous lymphocytes, the sample was considered basically qualified. If the results only showed blood cells, epithelial cells, or necrotic material, the sample was considered unqualified. If the ROSE results indicated the presence of cancer cells and an adequate number of cells, additional punctures in the same location were considered. However, if the ROSE results deemed the sample unqualified or if the sample was qualified but few cancer cells were observed, the puncture site was changed. The specific number of punctures was determined by the operator, with no more than four punctures per lesion (18). Similar to the NGA group and the GA group, tissue samples and cytological smears obtained from the RGA group were sent for pathological examination and cytological pathological examination, respectively.

Diagnosis

If the tissue specimens or cytological specimens obtained by EBUS-TBNA yield a definitive pathological diagnosis, it was considered the final diagnosis. If the tissue specimens or cytological specimens did not yield a definitive pathological result, but the patient obtained a definitive pathological diagnosis through other means such as surgical procedures, lymph node biopsy, percutaneous lung puncture, thoracoscopy, or further examination, the pathological diagnosis obtained through these means was considered the final diagnosis. If the specimens obtained by EBUS-TBNA did not yield a definitive pathological diagnosis and the patient did not undergo further diagnostic procedures at that time, imaging follow-up for at least 6 months was conducted, and the clinical diagnosis at that time was considered the final diagnosis.

Statistical analysis

Data were analyzed using SPSS 26.0 statistical software. Continuous variables were expressed as mean ± standard deviation, and categorical variables were expressed as frequencies (percentages). One-way analysis of variance (ANOVA) was used for comparisons of continuous variables among the three groups. Post-hoc pairwise comparisons were conducted using the Scheffe method (homogeneous variance) and the Games-Howell method (heterogeneous variance). The Chi-squared test was used for comparisons of categorical variables. A two-tailed P value <0.05 was considered statistically significant.

Results

The study flow diagram is shown in Figure 1 and the baseline data and puncture status of patients in each group are shown in Table 1. A total of 220 patients were included in the study, consisting of 162 males and 58 females. There were 71 patients in the NGA group, 77 in the GA group, and 72 in the RGA group. There were no statistically significant differences in age or gender distribution. Post-EBUS-TBNA analysis revealed no significant differences in the diameter of the masses or the short axis of the lymph nodes among the three groups. However, the number of punctures in both masses and lymph nodes was significantly lower in the RGA group compared to the other two groups (P<0.001). A total of 42 masses and 249 lymph nodes were punctured. Among all the lymph node, the 4R and 7 lymph nodes were the most frequently punctured sites.

Figure 1 Flow chart of study inclusion. EBUS-TBNA, endobronchial ultrasound-guided transbronchial needle aspiration; ROSE, rapid on-site evaluation; NGA, non-general anesthesia; GA, general anesthesia; RGA, general anesthesia with ROSE.

The diagnostic outcomes of EBUS-TBNA are shown in Table 2. A total of 177 patients received definitive diagnoses. In the NGA group, 54 patients were diagnosed, including 12 with squamous cell carcinoma, 22 with adenocarcinoma, 11 with small cell carcinoma, 1 with large cell carcinoma, 1 with non-small cell lung cancer (NSCLC), 4 with extrathoracic malignancies, and 3 with benign diseases. In the GA group, 61 patients were diagnosed, including 12 with squamous cell carcinoma, 28 with adenocarcinoma, 18 with small cell carcinoma, 1 with NSCLC, 1 with an extrathoracic malignancy, and 1 with a benign disease. In the RGA group, 62 patients were diagnosed, including 10 with squamous cell carcinoma, 22 with adenocarcinoma, 15 with small cell carcinoma, 1 with large cell carcinoma, 5 with NSCLC, 4 with extrathoracic malignancies, and 5 with benign diseases. There were 43 patients who did not receive a definitive diagnosis through EBUS-TBNA. In the NGA group, there were 17 such cases. Among these, 3 were confirmed by surgery (1 squamous cell carcinoma, 1 adenocarcinoma, 1 lung abscess), 4 by other invasive procedures (2 adenocarcinomas, 1 lymphoma, 1 breast cancer metastasis to the lung), 4 by follow-up (1 tuberculosis, 3 inflammatory lymph node hyperplasia), and 6 by second biopsy (2 squamous cell carcinomas, 2 adenocarcinomas, 2 small cell carcinomas). In the GA group, there were 16 undiagnosed cases. Among these, 3 were confirmed by surgery (1 squamous cell carcinoma, 1 adenocarcinoma, 1 large cell carcinoma), 3 by lymph node biopsy (2 adenocarcinomas, 1 tuberculosis), 5 by follow-up (1 nasopharyngeal carcinoma, 1 lung abscess, 3 inflammatory lymph node hyperplasia), 4 by second biopsy (1 squamous cell carcinoma, 1 adenocarcinoma, 2 small cell carcinomas), and 1 by next-generation sequencing (NGS) as tuberculosis. In the RGA group, there were 10 undiagnosed cases. Among these, 1 was confirmed as malignant thymoma by percutaneous lung biopsy, 3 by dynamic follow-up (1 adult Still’s disease, 1 tuberculosis, 1 inflammatory lymph node hyperplasia), 2 adenocarcinomas by second biopsy, 2 tuberculosis cases by NGS, and 2 were confirmed by surgery after changes were observed during follow-up (1 lymphoma, 1 tuberculosis).

Regarding complications, a total of 10 patients across the three groups experienced significant bleeding that required additional pharmacological intervention. In the NGA group, two patients experienced bleeding exceeding 50 mL. One patient was treated with 6 units of pituitrin (1 mL) diluted in 250 mL of 5% glucose solution administered via intravenous infusion, while the other patient was treated with 4 units of hemocoagulase diluted in 20 mL of saline, administered in multiple intravenous injections. Three patients had bleeding less than 50 mL, they were treated with 2 units of hemocoagulase applied locally in one case and administered as an intravenous injection in other cases. In the GA group, two patients had bleeding, both of whom were treated with 2 units of hemocoagulase applied locally. In the RGA group, three patients experienced bleeding. Two of them received 2 units of hemocoagulase applied locally, and one received it as an intravenous injection. Bleeding in all cases was successfully controlled following treatment, no patient required surgical or interventional procedures. Patients in the NGA group appeared more prone to hypertension, while those under general anesthesia were more likely to develop hypotension. No cases of pneumothorax, mediastinal emphysema, or hypoxemia requiring mechanical ventilation occurred postoperatively (Table 3).

The disease diagnosis rates for the three groups are shown in Figure 2. The diagnosis rates for malignant tumors were 80.95% in the NGA group, 85.71% in the GA group, and 93.44% in the RGA group, with no statistically significant differences between the groups (P=0.12). The overall disease diagnosis rates were similar between the NGA group (76.06%) and the GA group (79.22%), while the RGA group had a rate of 86.11%; however, these differences were also not statistically significant (P=0.30). In addition, among the 72 patients who underwent ROSE, 46 patients had positive ROSE results, and all were definitively diagnosed through EBUS-TBNA, achieving a diagnostic rate of 100%. In contrast, only 16 of the 26 patients with negative ROSE results received a definitive diagnosis, with a significantly lower diagnostic rate of 61.54% (P<0.001).

Figure 2 Malignant tumors and overall diagnosis rate of patients in three groups. NGA, non-general anesthesia; GA, general anesthesia; RGA, general anesthesia with ROSE; ROSE, rapid on-site evaluation.

The follow-up survey results are shown in Figure 3. The number of patients willing to undergo repeat EBUS-TBNA was 47 (66.20%) in the NGA group, 66 (85.71%) in the GA group, and 63 (87.5%) in the RGA group, with the differences being statistically significant (P=0.002).

Figure 3 Postoperative willingness survey of three groups. EBUS-TBNA, endobronchial ultrasound-guided transbronchial needle aspiration; NGA, non-general anesthesia; GA, general anesthesia; RGA, general anesthesia with ROSE; ROSE, rapid on-site evaluation.

Discussion

As a malignant tumor with high incidence and mortality rates, lung cancer often metastasizes to lymph nodes. The tumor-node-metastasis (TNM) staging, particularly the N stage, frequently determines the treatment and surgical approach for patients (19-21). Since its introduction to China in 2008, EBUS-TBNA has seen significant development and has become the first-line method for diagnosing unexplained mediastinal or hilar lymphadenopathy. Its high accuracy, minimal invasiveness, and quick and simple procedure have made it highly favored among clinicians.

In many medical centers both domestically and internationally, EBUS-TBNA is routinely performed on an outpatient basis. Local anesthesia combined with intravenous analgesia and sedation is often the preferred anesthetic method for outpatient procedures due to its simplicity and low cost. However, a drawback is that some patients experience uncontrollable coughing and cannot tolerate the procedure, which can affect the examination results and prolong the operation time. Under general anesthesia, patients experience no pain and are unconscious, with their airways remaining open. This significantly suppresses spontaneous breathing and coughing, facilitating smoother operation for the practitioner. Additionally, in cases of severe complications like massive bleeding, general anesthesia allows for more effective management. In our study, the NGA group required the highest number of punctures, potentially increasing risks for patients. Regarding the impact on diagnostic outcomes, a retrospective analysis by Yarmus et al. (5) involving 309 patients indicated that using propofol for deep sedation during EBUS-TBNA improved diagnostic efficiency compared to moderate sedation with fentanyl and midazolam. However, a subsequent randomized controlled study by Casal et al. (6) found that the diagnostic efficacy and major complication rates of EBUS-TBNA under general anesthesia were comparable to those under moderate intravenous sedation. Further research also supports that the type of anesthesia does not influence diagnostic outcomes (7,22). This is consistent with the findings of our study, where although the malignant tumor diagnosis rate and overall diagnosis rate were higher in the GA and RGA groups compared to the NGA group, the differences were not statistically significant.

Compared to empirical needle aspiration guided by ultrasound, the introduction of ROSE provides a more definitive direction for selecting the biopsy site. As with the impact of anesthesia methods, clinicians are most concerned with whether such a technique can benefit diagnostic accuracy. Three retrospective studies involving Chinese patients have shown that EBUS-TBNA combined with ROSE can improve diagnostic efficiency and reduce the number of needle passes (11-13). Additionally, two studies on molecular testing of samples obtained through EBUS-TBNA indicated that combining ROSE during biopsy in lung cancer patients avoided some repeated invasive diagnostic procedures and reduced the number of needle passes (14,23). A meta-analysis published in Chest concluded that combining ROSE with TBNA did not improve diagnostic efficiency or reduce procedure time, but using ROSE with EBUS-TBNA did reduce the number of needle passes (15). Two other studies have concluded that using ROSE during EBUS-TBNA for specimen collection or standardized mediastinal staging does not affect diagnostic rates or clinical decision-making (17,24). In summary, most studies suggest that EBUS-TBNA combined with ROSE can reduce the number of needle passes, though the benefit to diagnostic efficiency remains inconclusive. Currently, no comprehensive analyses exist on the impact of anesthesia combined with ROSE on the diagnostic efficiency of EBUS-TBNA. In our study, we found that the RGA group had higher malignant tumor diagnostic rates and overall disease diagnostic rates compared to the other two groups. Although this difference was not statistically significant, it might be due to the relatively small sample size of our study. General anesthesia combined with ROSE can improve patient comfort and reduce the number of lymph node punctures. Regarding complications, a total of 10 patients experienced significant bleeding, with half of these cases occurring in the NGA group. Two cases had bleeding volumes exceeding 50 mL. One case involved the puncture of a highly vascularized tumor, while the other case likely resulted from a puncture site shift due to severe coughing. It is important to note that the recorded bleeding volume was based largely on the operator’s subjective judgment and the volume aspirated during the procedure, which may have exaggerated the severity of the bleeding. No patients experienced severe complications or anesthesia-related adverse reactions, indicating that the use of general anesthesia during EBUS-TBNA is generally safe.Therefore, general anesthesia combined with ROSE may still offer diagnostic and other clinical benefits compared to local anesthesia with intravenous analgesia and sedation.

There are some limitations. First, it is a retrospective analysis with a limited number of cases, and the gender distribution in the NGA group differed from the other two groups, which may have influenced the results. Moreover, due to the lack of objective data, we could not perform a more comprehensive and in-depth analysis of the three groups. Further research is needed to confirm whether general anesthesia and ROSE can provide more clinical benefits.

Conclusions

In conclusion, performing EBUS-TBNA under general anesthesia is comfortable and safe. Compared to local anesthesia combined with intravenous analgesia and sedation, as well as general anesthesia alone, general anesthesia combined with ROSE can reduce the number of needle passes required during EBUS-TBNA. However, it does not further improve diagnostic efficacy.

Acknowledgments

Funding: This research was supported by the Natural Science Foundation of Sichuan Province (No. 2023NSFSC0527) and the Research Projects Fund of Southwest Medical University (No. 2022QN052).

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1117/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1117/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1117/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1117/coif). All authors report the funding from the Natural Science Foundation of Sichuan Province (No. 2023NSFSC0527) and the Research Projects Fund of Southwest Medical University (No. 2022QN052). The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). This study was approved by the Ethics Committee of The Affiliated Hospital of Southwest Medical University (No. KY2023314), and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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