|Year : 2018 | Volume
| Issue : 7 | Page : 1632-1637
Clinical application of planar puncture template-assisted computed tomography-guided percutaneous biopsy for small pulmonary nodules
Zhe Ji1, Guan Wang2, Baoming Chen2, Yuwei Zhang3, Li Zhang4, Fuchun Gao3, Shude Chai5, Bin Huo5, Guangjun Zheng5, Xiaodong Huo5, Baoming Wang6, Xudong Zhu6, Dan Meng6, Lejun Liu6, Rui Zhu6, Mingyong Han7, Ying Zhang7, Kaixian Zhang8, Junjie Wang9
1 Department of Radiation Oncology, Peking University Third Hospital, Beijing; China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei, PR China
2 China Northern Radioactive Brachytherapy Group; Department of Nuclear Medicine, Tangshan People's Hospital, Tangshan, Hebei, PR China
3 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital; Department of Oncology, Luanxian People's Hospital, Tangshan, Hebei, PR China
4 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital; Department of Oncology, Luanxian People's Hospital, Tangshan, Hebei, PR, China
5 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei; Department of Thoracic Surgery; Department of Oncology, The Second Hospital of Tianjin Medical University, Tianjin, PR China
6 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei; Department of Radiation Oncology, Zouping Hospital of Traditional Chinese Medicine, Zouping, Shandong, PR China
7 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei; 8Department of Health Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong, PR China
8 China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei; Department of Oncology, Tengzhou Central People's Hospital, Tengzhou, Shandong, PR China
9 Department of Radiation Oncology, Peking University Third Hospital, Beijing; China Northern Radioactive Brachytherapy Group, Tangshan People's Hospital, Tangshan, Hebei, China
|Date of Web Publication||19-Dec-2018|
Department of Radiation Oncology, Peking University Third Hospital, Beijing
Source of Support: None, Conflict of Interest: None
Aims: The aims of this study were to evaluate the clinical application of planar puncture template (PPT) in computed tomography (CT)-guided percutaneous needle lung biopsy.
Subjects and Methods: A total of 56 patients with small pulmonary nodules who received CT-guided percutaneous lung biopsy assisted by PPT were included in the study. Five steps were included in the study: fixing position, CT scanning and designing needle pathway, installing navigation system and template, puncturing fixation needle, and performing biopsy needle insertion and biopsy. The success rate of puncture, pathological results, and complications were analyzed. In addition, the factors that influenced the success rate and complications were analyzed.
Results: Biopsy was successfully completed in all 56 patients. The nodule diameter was 0.45–3 cm. The fixation needle technique was applied in 47 cases. Biopsy was performed 1 time in 50% of patients and 2 times in 38% of patients. For pathology, only one case showed no positive result, with a puncture success rate of 98%. The diagnostic rate of malignant tumor was 73%. For complications, the incidence of needle tract bleeding was 68%, the incidence of pneumothorax was 30%, and the thoracic drainage was required in two patients. Hemoptysis was observed in two cases. Univariate analysis: The nodule size was related to both the rate of 1-time biopsy and incidence of complications. Smaller nodule was relevant to lower rate of 1-time biopsy (P = 0.01) and higher incidence of complications (P < 0.05). The fixation needle was related to 1-time biopsy rate. The 1-time biopsy rate was significantly higher in patients with fixation needle than those without fixation needle (P = 0.001). Meanwhile, no significant difference was observed in the incidence of complications in different number of fixation needles (P > 0.05).
Conclusions: PPT-assisted lung biopsy technology can provide high success rate and low complication incidence. It would be helpful to make the puncture procedures more standard for better clinical applications.
Keywords: Computed tomography guided, percutaneous needle lung biopsy, planar template, small pulmonary nodule
|How to cite this article:|
Ji Z, Wang G, Chen B, Zhang Y, Zhang L, Gao F, Chai S, Huo B, Zheng G, Huo X, Wang B, Zhu X, Meng D, Liu L, Zhu R, Han M, Zhang Y, Zhang K, Wang J. Clinical application of planar puncture template-assisted computed tomography-guided percutaneous biopsy for small pulmonary nodules. J Can Res Ther 2018;14:1632-7
|How to cite this URL:|
Ji Z, Wang G, Chen B, Zhang Y, Zhang L, Gao F, Chai S, Huo B, Zheng G, Huo X, Wang B, Zhu X, Meng D, Liu L, Zhu R, Han M, Zhang Y, Zhang K, Wang J. Clinical application of planar puncture template-assisted computed tomography-guided percutaneous biopsy for small pulmonary nodules. J Can Res Ther [serial online] 2018 [cited 2019 May 20];14:1632-7. Available from: http://www.cancerjournal.net/text.asp?2018/14/7/1632/247709
| > Introduction|| |
The qualitative diagnosis of small pulmonary nodules has been difficult for chest imaging diagnosis. However, computed tomography (CT)-guided percutaneous needle lung biopsy can directly access the target tissues, which has been considered as an important measure for diagnosis. It considered that CT-guided free-hand biopsy was not particularly feasible for small pulmonary nodules. The reasons were the smaller size of small pulmonary nodules, which would always move following respiratory motion. In addition, it was difficult to complete biopsy successfully at one time. The complications of puncture such as pneumothorax, bleeding, and atelectasis would also be increased. In clinical practices, how to improve the success rate and safety of puncture for biopsy of small pulmonary nodules has been a lasted problem for clinicians. Since 2016, three-dimensional (3D) printing noncoplanar template has been applied in the field of radioactive seed implantation. With the guidance of template, the accuracy, efficiency, and safety of puncture could be improved., In this study, we collaboratively involved 3D printing planar template with digital navigation system, which was named as planar puncture template (PPT). By applying PPT in CT-guided percutaneous biopsy for small pulmonary nodules, a good outcome was obtained and reported as follows.
| > Subjects and Methods|| |
In this study, a total of 56 patients with small pulmonary nodules were included in the study, who received CT-guided percutaneous lung biopsy assisted by PPT from January 2016 to March 2017 in our department. There were 41 males and 15 females, with median age of 60 years old. Inclusion criteria were as follows: (1) the diameter of the lung nodules was ranged from 0.45 to 3 cm (mean 1.5 cm); (2) there was an appropriate puncture path which could avoid ribs, pulmonary vessels, and emulous emphysema; and (3) patient was tolerable to puncture. Exclusion criteria were as follows: (1) severe emphysema and pneumatocele; (2) coagulation dysfunction and hemorrhagic diseases; and (3) serious infection. The general conditions of patients were shown in [Table 1]. The study was approved by the institutional review board of our hospital. Informed consent was obtained from all patients involved in this study.
PPT, three-axis coordinate navigation frame, angle-measuring instrument (Tangshan Tongrenhe Technology Co. Ltd.), negative pressure position fixing pad, 16-slice spiral CT with large borehole (Philips Co. Ltd), 18-gauge coaxial cutting needle biopsy (Argon Medical Device, Inc.), and 18-gauge radioactive seed implantation needle (17.5 cm, Mick Radio-Nuclear Instruments, Inc.) which was applied as the fixation needle were used in this study.
Patient set-up and fixation
The planned puncture path was designed according to the recent imaging data of patients. An appropriate position was selected for patients based on the relationship between the target lesion and surrounding structure. Then, negative pressure vacuum bag was applied for fixing the patients and make them feel as comfortable as possible.
Location of puncture point
CT scan was performed on the planned puncture point with layer thickness of 1 mm to clearly show the location of nodules. Basically, we designed the puncture path on the CT layer which presented the maximum cross-section of the target nodule, determined the planned puncture points on the skin surface, and recorded puncture angle. With the help of the positioning laser line, the location of the puncture points indicated by CT would be projected onto the surface of the patient. Then, cross marks would be made on the surface of the patient based on the positioning laser line.
Installation of navigation system and template
The three-axis coordinate navigation frame was installed on the same side of lesion and connected with the angle-measuring instrument. Then, PPT was set up on the navigation frame. Thus, template could be adjusted in all directions (X-, Y-, and Z-axis) to match the crossline on the body surface of patient and laser positioning line. Finally, the angle of template was adjusted for meeting our demand [Figure 1].
|Figure 1: Planar puncture template and three-axis coordinate navigation frame installation|
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Computed tomography-guided percutaneous biopsy of pulmonary nodules
We deployed routine sterilization and infiltration anesthesia with lidocaine (concentration 1%). The fixation needles were inserted around the puncture point within the range of 0.5–1 cm. Then, the depth and direction of the needle were verified to be consistent with preplan by CT scan (if there was deviation, real-time adjustment should be performed). Next, fixation needle was pushed into the position of lesions or near the lesions [Figure 2]. The relative position of biopsy needle was adjusted based on the location of fixation needle and template coordinates. Then, the coaxial biopsy needle punctured into the proximal region of lesions [Figure 3] (if there was deviation, real-time adjustment should be performed). For each patient, we planned to conduct one or two times of biopsy until the satisfactory specimen was obtained. Then, the collected specimen was immersed into formalin to be fixed and send for pathological examination. Finally, we bound up the wound at puncture point and performed CT scan to observe if there were complications such as pneumothorax and bleeding. If there was free gas in the thoracic cavity, it could be judged as postpuncture pneumothorax. If there was pulmonary hemorrhage, ground-glass density or high-density exudation, and free liquid, it could be judged as postpuncture bleeding, requiring symptomatic treatment and close attentions for 6 h. The workflow was shown in [Figure 4].
- The accuracy of puncture: According to the pathological results, it was judged as success when the pathology indicated positive results or as failure when pathology reported necrotic or lung tissue
- Complications of puncture: Hemorrhage, pneumothorax, and hemoptysis.
Statistical analysis was performed on Chi-square test by SPSS Statistics version 20 (IBM Corp., Armonk, New York State, USA). Difference was considered statistically significant at P < 0.05.
| > Results|| |
The puncture operation was successfully performed in a total of 56 patients. Thirty-four cases were punctured with two fixation needles, 13 cases were punctured with one fixation needle, and 9 cases were punctured without fixation needle. Eighty-eight percent of patients (49 cases) experienced one or two times of biopsy and 12% of patients (7 cases) experienced three or four times of biopsy because the specimens were not satisfied [Table 2]. For pathological results [Table 3], only one case showed no positive results. The success rate of puncture was 98% (55/56) and malignant tumor diagnosis rate was 73% (41/56). Diagnosis rate of malignant tumor was 71% (32/45) and 81% (9/11) for the first visit and reexamination patients, respectively. Among 32 cases of non-small cell lung cancer, there were 25 cases of adenocarcinoma, 5 cases of squamous cell carcinoma, and 1 cases of large cell. The other one case could not be classified.
The incidence of needle bleeding and pneumothorax was 68% (38/56) and 30% (17/56), respectively. Pleural drainage was necessary in 4% of patients (2/56). Hemoptysis was observed in two cases (4%). All the patients with complications were cured after symptomatic treatments [Table 4]. Further analysis of subgroup showed that the lesion size was associated with one needle biopsy rate and complication incidence. Smaller lesion was related to lower one-time biopsy (P = 0.010) and higher incidence of complications (pneumothorax, P = 0.049; needle bleeding P = 0.007) [Table 5].
|Table 5: The effect of different diameters of lesions on the rate of one-time biopsy and complications|
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The number of the fixation needles was related to the rate of one-time biopsy. The biopsy rate in patients with fixation needle was significantly higher than those without fixation needle (P = 0.001), while the number of the fixation needles had no significant effect on the rate of one-time biopsy. At the same time, there was no significant correlation between the number of fixation needles and the incidence of complications (pneumothorax, P = 0.562; needle bleeding P = 0.487) [Table 6].
|Table 6: The effect of different number of fixation needles on the rate of one-time biopsy and complications|
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| > Discussion|| |
Due to the small size of pulmonary nodules and its continuous moving with breathing, more accurate approach has been necessary for puncture. CT guidance is most commonly applied for puncture. In past clinical practices, the puncture sites were determined through the positioning grid and the operation was performed by free hand. There were many shortcomings: (1) due to the error in the judgment of puncture angle, needle was prone to deviate from original direction. The direction and depth of puncture needle often needed to be adjusted for several times. All these factors prolonged the time of puncture and increased the risk of pneumothorax and intrapulmonary bleeding. (2) The skill and experience of operators were essential for the outcome of operation, making a significant effect on the accuracy and safety. In general, it took a long time to train an experienced puncture physician; thus, the establishment of standardization, popularization, and promotion would be limited. (3) The X-ray radiation received by the patients would be increased with repeated CT scan.
PPT was based on the parallel matrix template used in standardized radioactive seed implantation for prostate cancer. During the process of radioactive seed implantation, accurate puncture on prostate lesion can be achieved with the guidance of the perineal template, resulting in great improvements for treating prostate cancer. (1) PPT was made by layer-by-layer 3D printing technology, making small and densely covered holes within the template. When bleeding occurred at the puncture point on the body surface, blood would infiltrate into the template and coagulate inside, which decreased the risk of bleeding. (2) 3D printing technology greatly reduced the pinhole error and promoted the compatibility among the needle tracts and needles, which ensured the smooth of puncture. (3) A cross axis was designated at the center of template, and the relative position of template and needle could be precisely adjusted. (4) The template was single use to avoid cross infection caused by repeated use.
The accuracy of puncture depended on multiple factors. It was reported that the success rate of lung biopsy was decreased with the decreased diameter of lesion (100% to 66.7% corresponding to diameter ranged from 70 to 6 mm). Zhao et al. analyzed the data of 155 patients who had suffered pulmonary nodule puncture, suggesting that the accuracy of puncture with nodule diameter >20–30 mm was much higher than that of <20 mm (97% vs. 85%). Based on the risk assessment criteria on “China National Guideline of Classification, Diagnosis and Treatment for Lung Nodules (2016 Version),” pulmonary nodules were divided into three groups (<5 mm, 5–15 mm, and ≥15 mm). The success rate of one-time biopsy was increased with the increased nodule diameter, with statistically significant difference (P = 0.010). Moreover, even the specimen collected at the first time was not satisfied, we could still obtain positive results through increasing the number of biopsy, and thus, the overall success rate of puncture was 98%. It can be considered that with the guidance of PPT and coordinate navigation frame, the puncture path could be effectively controlled. Furthermore, we were able to digitally describe the puncture point and angle of needle, which could markedly enhance the accuracy of puncture.
In addition, the information provided by CT scanning was static, while the negative pressure vacuum pad overcomes the problem of postural changes of patients. However, the deviation between the mark on the body surface and pulmonary nodule inside the body could not be ignored, which may be attributed to respiratory movement. For the puncture of small nodules, even the millimeter-scale deviation should be noticed. Therefore, fixation needle was applied to prelock the adjacent tissues of target lesion to restrict its movements during the puncture.,
The incidence of malignancy in our study was 73%, which was higher than that of reported in the literature (range from 10% to 68%). Consider for the following reasons: (1) in some cases (11 cases), the patients were diagnosed with cancer before, the diagnosis rate of malignant tumor was as high as 82% for these patients and (2) the diameters of most nodules (98%) were corresponding to an intermediate or high risk (39% for 5–15 mm, 59% for ≥15 mm).
The most common complication of CT-guided percutaneous biopsy of pulmonary nodules is pneumothorax, with an incidence of about 5% ~ 64%. In addition, the incidence of pneumothorax requiring indwelling catheter drainage was ranged from 2% to 21%.,, It was impossible to avoid the damage to the pulmonary blood vessels during the puncture. It was reported that the incidence of postoperative pulmonary hemorrhage was 26% ~ 33%,, and hemoptysis was about 1.2% ~ 5%. Other complications were relatively rare, such as pericardial tamponade, mediastinal hematoma, hematoma, air embolism, tumor dissemination, and plantation.,
The incidence of complications was related to the lesion size, puncture times, and the needle size. Zhang et al. reported that the incidence of pneumothorax after puncture was 4.6% and 19.3%, for the lesion with the diameters of >3 cm and ≤3 cm, respectively. Shi et al. reported that the incidence of pneumothorax and hemorrhage after the first puncture was 4.02% and 5.17%, respectively, and it was 9.77% and 13.22% after the second puncture. Other scholars believed that the risk of bleeding and pneumothorax would be increased when the diameter of the needle was more than 18 G. Therefore, the fine needle was more suitable for patients with vascular diseases. In our study, the total occurrence of pneumothorax was 30% (4% of severe pneumothorax) and hemoptysis was 4%, both of which were lower than that of reported in previous studies. However, the incidence of needle tract bleeding was higher (68%), which was relatively mild, and the patients could be quickly recovered. In addition, the application fine needle (18-gauge) to perform puncture biopsy would also contribute to reducing the incidence of complications. With this technology, the frequency of needle adjustment could be greatly reduced during the puncture. Even tiny lesions could be completed at one time, with fewer complications. In addition, this study showed that the smaller lesion was related to higher incidence of complications (P < 0.05), which was consistent with the results reported in previous studies. Furthermore, our study showed that the success rate of one-time biopsy was improved (P = 0.001) by adding the fixation needle, which did not increase the risk of complications (P > 0.05). Thus, it provided support for the further applications of fixation needle technology.
The purpose of this study was to summarize the process and technical characteristics of PPT-guided lung puncture biopsy, based on the preliminary clinical cases. Therefore, there were still many limitations: (1) The sample size was relatively small, and the data are only for early reference, which need more samples for further verification; (2) the technology was performed in a short time, the control group without PPT was not set, and the results were only compared with the data in the previous literature; and (3) the data which can compared with other navigation systems were not sufficient and comprehensive, such as the costs of the methodology, the execution time, and the radiation dose to patients. Elaborate data analysis would be collected in future studies.
PPT-assisted CT-guided percutaneous biopsy of small pulmonary nodules ushered a new stage in the field of CT-guided interventional therapy. It is noteworthy that this emerging technology greatly enhanced the accuracy and efficiency of puncture, reducing the occurrence of complications. With PPT technology, the impact of individual experience from different operators could be reduced to a certain extent, thus making the operation process more standardized. Prospective randomized studies with consistent cases and homogeneous groups of patients would be needed to further confirm these advantages.
| > Conclusion|| |
PPT-assisted lung biopsy is a good technology with high success rate and low complication incidence.
Financial support and sponsorship
This study was financially supported by The Clinical Characteristics Application of Research Projects in Capital (Z151100004015171).
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]