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(Chest. 2003;124:147-154.)
© 2003 American College of Chest Physicians

Usefulness of New Automated Cutting Needle for Tissue-Core Biopsy of Lung Nodules Under CT Fluoroscopic Guidance*

Takuji Yamagami, MD, PhD; Shigeharu Iida, MD; Takeharu Kato, MD; Osamu Tanaka, MD; Shogo Toda, MD, PhD; Daishiro Kato, MD, PhD and Tsunehiko Nishimura, MD, PhD

* From the Departments of Radiology (Drs. Yamagami, Iida, T. Kato, Tanaka, and Nishimura) and General Thoracic Surgery (Drs. Toda and D. Kato), Kyoto Prefectural University of Medicine, Kyoto, Japan.

Address requests to: Takuji Yamagami, MD, PhD, Department of Radiology, Kyoto Prefectural University of Medicine, 465 Kajii, Kawaramachi-Hirokoji, Kamigyo, Kyoto, 602-8566, Japan; e-mail: yamagami{at}koto.kpu-m.ac.jp


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Objectives: The goal of our study was to evaluate the efficacy and safety of a new type of automated cutting needle for tissue-core lung biopsy under real-time CT fluoroscopic guidance.

Design: Observational

Materials and methods: One hundred ten percutaneous needle tissue-core lung biopsies were performed with the Auto Surecut needle (Create Medic; Yokohama, Japan) under CT fluoroscopic guidance, and the specimens obtained underwent histopathologic evaluation. A final diagnosis was confirmed by independent surgical pathology.

Results: The rate of success for the diagnosis for specimens that were adequate for histopathologic analysis was 94.5% (104 of 110 specimens). The sensitivity, specificity, and accuracy in diagnosing malignancy were 95.1%, 100%, and 96.2%, respectively. A specific cell type could be characterized in 95.2% of those 104 lesions (99 lesions; malignant, 76 lesions; benign, 23 lesions). The specific cell type was precisely diagnosed, and was confirmed after surgery in 65 malignant lesions and 23 benign lesions. The biopsy-induced complications encountered were pneumothorax in 34.5% (38 of 110 patients) and hemoptysis in 6.4% (7 of 110 patients). No patient had a serious complication.

Conclusion: CT fluoroscopy-guided lung biopsy using the Auto Surecut needle provides a high degree of diagnostic accuracy, allows for the specific characterization of lung nodules, and can be performed safely.

Key Words: biopsies • CT • guidance • lung biopsy • technology


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
CT scan-guided needle biopsy of lung nodules has become a well-established diagnostic technique.1 The modalities commonly employed for this image-guided percutaneous needle biopsy include fluoroscopy,2 conventional CT scanning,1 3 and helical CT scanning,3 which is now more widely used. CT fluoroscopy, which was developed most recently, has simplified the process and has decreased the time required for CT scan-guided needle biopsies.4 5

Most CT scan-guided lung biopsies cited in earlier reports6 7 were performed with fine-needle aspiration for cytology and were useful in differentiating malignant from benign lesions. In addition, a tissue-core biopsy utilizing a cutting needle, which enables the histopathologic evaluation of the samples obtained,8 has been implemented to enhance diagnostic ability. Owing to the development of an automated spring-driven cutting needle, tissue-core biopsy can now be performed more easily and higher quality core specimens can be obtained for histopathologic analysis.9 10 11 12 13 14 15

The various kinds of cutting needles can be divided roughly into the following two types: the modified Tru-Cut needle9 10 11 12 13 14 15 16 17 18 ; and the modified Menghini-type needle.8 17 18 19 20 21 The Tru-Cut type of needle consists of an outer cutting cannula and an inner trocar that contains the specimen notch. In general, the following procedure is used with this type of needle. When the tip of the biopsy needle reaches the lesion, the inner trocar is thrust forward, followed by a forward thrusting of the outer cutting cannula. The specimen then is trapped in the notch of the trocar when the cutting cannula is advanced. The Menghini needle, which is also known as a "full-cut type needle,"17 18 consists of an inner trocar that does not have a notch and an outer cutting cannula. When the tip of the biopsy needle reaches the lesion, the outer cutting cannula is advanced, while the inner trocar is held stationary, and the tissue-core is captured inside the outer cannula. The Menghini-type needle creates a vacuum in the end of the outer needle when the outer cutting cannula is thrust forward.

Theoretically, considering the structure of each type of cutting needle, if needles of the same diameter were compared, the modified Menghini-type needle, which can obtain a tissue core corresponding to the full caliber of the outer cutting cannula, might more effectively obtain a specimen compared with the modified Tru-Cut needle. With the latter, the tissue core is restricted to the volume accommodated by the notch. However, currently, the majority of automated spring-driven cutting needles that are widely accepted are of the modified Tru-Cut type.9 10 11 12 13 14 15 16 17 18 The usage of automated needles of the modified Menghini type has been limited.17 18 21 Some researchers17 have pointed out that the reason for the difficulty in using the automated needle of the modified Menghini type, which has been commercially available, for lung biopsy is the large number of biopsies that do not obtain a specimen.

More recently, a new automatic, spring-driven cutting needle, which is a modified Menghini-type needle, became commercially available. The purpose of the present study was to evaluate the feasibility and safety of this new needle in performing CT fluoroscopy-guided, needle tissue-core biopsy of lung nodules.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Subjects
Patients who required percutaneous needle biopsies of the lung under real-time CT fluoroscopic guidance between April 1998 and December 2001 in our institution were considered for inclusion in this retrospective study. The criteria for inclusion were as follows: (1) patient had undergone percutaneous tissue-core biopsy of a lung nodule, which had been performed with the new automated needle biopsy device; and (2) the patient had received a final histopathologic diagnosis after undergoing surgery. Among the 108 patients satisfying the above criteria, 110 lung nodules had been examined (46 women and 62 men; mean age, 66.5 years; age range, 16 to 90 years). Two patients each underwent needle biopsies for two lesions. The mean (± SD) diameter of the lesions was 19.9 ± 9.2 mm (range, 3 to 45 mm). The mean depth of the lesions, as measured from the pleural surface to the edge of the mass, was 14.8 ± 15.7 mm (range, 0 to 63 mm).

Biopsy Needle
A 20-gauge needle (Auto Surecut; Create Medic; Yokohama, Japan) was used for the tissue-core biopsy. The Auto Surecut needle is a modified Menghini-type needle that consists of an outer cutting cannula with a coring point, and an inner trocar with an angle and sharp tip (Fig 1 , top). Inside the body of the cutting needle device, a closed microsyringe is attached to the edge of the outer cutting cannula (Fig 1 , bottom). By operating a trigger, the outer cutting cannula is automatically extended to a length of 2.2 cm, while at the same time a vacuum is established in the biopsy channel, resulting in negative pressure at the tip of the outer cannula. Details of this mechanism and directions for the use of the device can be obtained from the manufacturer (Create Medic).



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  		Figure 1.. Top: photograph shows the proximal part of the outer cutting cannula (bottom) and that of the inner trocar (top). The edge of the outer cutting cannula is attached to a microsyringe (arrow). Bottom: the top image shows the proximal part of the cutting needle assembly with the inner trocar and outer cutting cannula. The bottom image shows the inside of the body of the cutting needle device (arrowhead), from which the cover is detached. The spring is loaded over a microsyringe equipped with an outer cutting cannula (arrow), within which the inner trocar is assembled.

 
Biopsy Procedures
All patients had undergone diagnostic CT scans of the chest with 10 mm-thick contiguous axial tomographic sections before undergoing the biopsy. At the time of the biopsy, preliminary helical CT scan images (X Vigor Laudator; Toshiba Medical System; Tokyo, Japan) were obtained in 5 mm-thick sections through the lesion. From a review of these preliminary images, patient position, level of the needle entry site, and direction of the approach were planned to provide the most direct route for the biopsy, to traverse the least amount of aerated lung, and to avoid bullae and fissures. During the biopsy, patients assumed a supine position (45 patients), a prone position (49 patients), or a lateral position (16 patients).

The procedure was performed by one of three interventional radiologists who were experienced in CT scan-guided biopsy after obtaining informed consent from the patient. A CT fluoroscopic imaging system was used for all of the CT scan-guided biopsy procedures. The details of the CT fluoroscopy have been described elsewhere.22 The CT beam width was collimated to 3 mm. The imaging parameters during CT fluoroscopy included a CT beam width collimated to 3 mm, a tube voltage of 120 kilovolt peak, a current of 30 to 50 mA, and a scanning speed of 0.75 s per rotation (360°).

Each CT scan-guided lung biopsy procedure was performed in a stepwise manner with the quick application of CT fluoroscopy to confirm the path of the needle, while meticulous care was taken to minimize direct radiation to the operator’s hands. Details of the biopsy procedure were described in our previous report.23 After confirming that the tip of the inner trocar had reached the margin of the lesion (Fig 2 , top), the trigger was pushed, then the outer cutting cannula was pushed into the lesion (Fig 2 , bottom). After confirming that the outer cannula had penetrated the lesion, the needle was slightly rotated, then was withdrawn. The obtained specimen was pushed out with the inner trocar. When the operator was uncertain as to whether the needle-tip had reached the lesion or whether the specimen was insufficient, a repeat biopsy was performed. An on-site cytopathologist was not present, and frozen-section analysis could not be performed at the time of biopsy in our institution.



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  		Figure 2.. CT scan images of a 76-year-old woman with metastatic lung cancer. Top: a real-time CT fluoroscopic scan with patient in the prone position shows that the tip of the inner trocar has been advanced to the margin of the lesion of the left lower lobe. Bottom: a real-time CT fluoroscopic scan shows that the outer cutting cannula is penetrating the nodule.

 
All biopsy procedures were performed with the patient under local anesthesia. After the biopsy procedure, axial CT scan images were obtained during a single breath-holding through the level of the biopsy or, if necessary, through the whole chest using helical CT scanning to evaluate for the presence of complications such as pneumothorax. While still on the scanner table, patients with a moderate or severe pneumothorax, or with symptoms of pneumothorax underwent immediate manual aspiration of air from the pleural space using an 18-gauge IV catheter23 or chest tube placement, if necessary. Those patients with pneumothorax were transferred to the recovery room where oxygen was administered by nasal cannula (100% at 3 L/min).

Specimens obtained by tissue-core biopsy were evaluated histopathologically. All histopathologic evaluations were performed by experienced chest cytopathologists. They were required not only to classify specimens as positive or negative for malignancy but also to identify specific cell types, such as adenocarcinoma or small cell carcinoma, in cases of malignant lesion, or, in cases of benign lesions, to diagnose conditions such as hamartomas or tuberculosis, if possible.

Investigated Parameters
The following parameters were retrospectively investigated: (1) the number of punctures; (2) the rate of success in obtaining sufficient samples for histopathologic evaluation; (3) the ability to determine whether the lesion was malignant or benign and to characterize specific cell types (both were compared with the results of independent surgical pathology); and (4) complications.


   Results
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 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
The mean (± SD) number of punctures using the Auto Surecut biopsy needle was 1.4 ± 0.7 (range, one to four punctures; median, one puncture).

Of 110 tissue-core biopsy procedures, specimens adequate for histopathologic evaluations were obtained in 104 (94.5%) [Table 1 ]. The biopsy was deemed to be inadequate if the specimens collected contained only blood or normal lung cells. Of the six lesions for which the specimen was inadequate, all were finally proven to be malignant by surgical pathologic findings (adenocarcinoma, two lesions; adenosquamous carcinoma, one lesion; large cell carcinoma, two lesions; and metastatic lung cancer, one lesion).


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  		Table 1.. Correlation Between Diagnoses Obtained From Needle Biopsy and Surgery

 
The identification of 104 lesions from which evaluable specimens were obtained by tissue-core biopsy was compared with the final diagnosis obtained by pathologic analysis after surgery (Table 2 ). Overall, 100 lesions were precisely identified. All 77 lesions that had been identified as malignant from the biopsy sample were proved to be malignant by surgical histopathology. Twenty-three of 27 lesions (85.2%) that had been identified as benign by needle biopsy were confirmed to be benign by surgical histopathology; however, the remaining 4 lesions finally were identified as malignant. In summary, sensitivity, specificity, and accuracy for the identification of malignant lesions were 95.1%, 100%, and 96.2%, respectively.


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  		Table 2.. Characterization of Specific Cell Type as Proved by Histopathologic Examination

 
The specific cell types revealed by needle biopsy were compared with those determined by surgical findings (Table 2) . The specific cell type was characterized by percutaneous needle tissue-core biopsy in 99 of 104 lesions (95.2%) from which an adequate specimen was obtained. Seventy-six of 77 lesions (98.7%) that had been identified as malignant and 23 of 27 lesions (85.2%) that had been identified as benign from samples obtained by needle biopsy were characterized specifically. Cell types determined by needle biopsy in 65 malignant lesions and 23 benign lesions were the same as those proven by surgical pathology. Table 3 provides information on the 16 lesions for which the characterization of specific cell types differed. It should be noted that all four lesions not characterized specifically and identified as having "no evidence of malignancy" were finally proven to be malignant (ie, lesions 13 to 16 in Table 3 ). However, the specific cell types of all benign lesions that were evaluated by needle biopsy also were assigned the same specific cell type by surgical histopathologic findings.


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  		Table 3.. Differences in Cell Types as Characterized From Specimens Obtained by Needle Biopsy vs Those by Surgical Histopathologic Findings

 
When lesion size was considered, as shown in Table 4 , the success rates in obtaining adequate specimens were 96.2% in lesions <= 1.0 cm (25 of 26 lesions), 95.2% in lesions > 1.0 cm and <= 2.0 cm (40 of 42 lesions), 91.2% in lesions > 2.0 cm and <= 3.0 cm (31 of 34 lesions), and 100% in lesions > 3.0 cm (8 of 8 lesions). The rates of success in determining whether a lesion was malignant or benign in the 104 lesions from which the specimen obtained was sufficient were 88.0% in lesions <= 1.0 cm (22 of 25 lesions), 97.5% in lesions > 1.0 cm and <= 2.0 cm (39 of 40 lesions), 100% in lesions > 2.0 cm and <= 3.0 cm (31 of 31 lesions), and 100% in lesions > 3.0 cm (8 of 8 lesions). The success rates in precisely characterizing specific cell types were 84.0% in lesions <= 1.0 cm (21 of 25 lesions), 82.5% in lesions > 1.0 cm and <= 2.0 cm (33 of 40 lesions), 90.3% in lesions > 2.0 cm and <= 3.0 cm (28 of 31 lesions), and 75.0% in lesions > 3.0 cm (6 of 8 lesions).


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  		Table 4.. Diagnostic Ability of Needle Biopsy Under CT Fluoroscopic Guidance According to Size of Lesion*

 
Regarding biopsy-induced complications, pneumothorax, which was the most frequent complication in the present study, was evident on CT scan images that had been obtained immediately after biopsy in 38 of the 110 procedures (34.5%). Immediate manual aspiration was performed in 19 of these patients, and further treatment with chest tube insertion was necessary in 4 patients. In 32 cases (29.1%), parenchymal hemorrhage along the route of the advancing biopsy needle was revealed on CT scan images obtained after the biopsy. In seven cases (6.4%), hemoptysis occurred after the biopsy. One patient had a subcutaneous hematoma around the region of needle insertion. None of the patients had serious complications.


   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
CT scan-guided lung biopsy is widely accepted as the principal method for evaluating lung nodules. The success rate in obtaining sufficient samples for cytohistologic evaluation (ie, the rate of adequate biopsy) has been reported to range from 80 to 100%.3 8 9 10 11 12 13 14 15 24 25 26 The most common complication of CT scan-guided lung biopsy is pneumothorax, with a frequency range of 17.9%3 to 54.3%11 according to previous reports.3 11 23 26 27 28 29 30 31 The frequency of chest tube placement was shown to range from 2.0%28 to 15.0%11 of all biopsy procedures. Hemoptysis and parenchymal bleeding are also well-known as biopsy-induced complications, with a frequency range of 2.0%31 to 10.1%10 and 5.1%12 to 42.0%,11 respectively. The technical success rate in obtaining adequate specimens and the frequency of biopsy- induced complications in the present study were similar to those cited in previous reports, suggesting no appreciable difference in subject and operator skill from those of earlier studies. The use of real-time CT fluoroscopic guidance may have been a reason for the high rate of technical success even as the size of the lesions decreased.

Undoubtedly, the purpose of lung biopsy is to differentiate malignant from benign lesions. Furthermore, it is needed to determine the specific cell type, especially to discern whether the lesion is small cell carcinoma or non-small cell carcinoma of the lung or metastasis, because treatment is selected based on this information. With regard to benign lesions, a clarification of the specific cell type also may be necessary. Otherwise, for example, a diagnosis of simply "negative for malignancy" would indicate the necessity for long-term follow-up or biopsy with another procedure,11 because in some cases lesions not identified according to specific cell type are found to be malignant on a second biopsy or follow-up study.2

Controversy exists about whether cytology or histology is more useful in the evaluation of lung nodules. However, histologic evaluation is more advantageous than cytology in making a specific diagnosis, especially in benign lesions,13 or if an on-site cytopathologist is absent or a frozen section analysis cannot be performed at the time of the biopsy.9 Previous reports of CT scan-guided tissue-core biopsies of lung nodules8 9 11 12 13 have shown that the specific cell type could be characterized in 60 to 99% of malignant lesions and in 44 to 91% of benign lesions that were evaluated histologically.

Currently, the use of the automated cutting needle in tissue-core biopsy is considered to be useful for obtaining specimens of lung nodules for histologic evaluation. In previous reports9 10 13 15 of CT scan-guided lung biopsy using an automated cutting needle, the rate of success in obtaining an adequate specimen ranged from 90 to 100%. The sensitivity, specificity, and accuracy of this method to diagnose malignancy precisely were reported to be 77 to 97%,9 11 12 13 71 to 100%,9 10 11 12 13 and 62 to 93%,9 10 11 12 13 14 respectively. Diagnostic accuracy has been shown to decrease with decreases in lesion size. Lucidarme et al,10 in a review of 89 consecutive patients who had undergone percutaneous tissue-core biopsy with an automated cutting needle biopsy system, found a lower but statistically insignificant degree of accuracy for lesions <= 2.0 cm compared with lesions > 2.0 cm (diagnostic accuracy for lesions <= 2.0 cm, 81%; diagnostic accuracy for lesions > 2.0 cm, 91%). Tsukada et al,12 utilizing CT scan-guided automated needle biopsy for lung nodules, described similar findings of diagnostic accuracy according to lesion size, as follows: 50 to 100 mm, 100%; 31 to 50 mm, 93.3%; 21 to 30 mm, 86.7%; 11 to 20 mm, 78.9%; and 6 to 10 mm, 66.7%.

In comparison, the ability to obtain adequate specimens and the diagnostic ability to detect malignant lesions in our study were at the high end, although the mean number of punctures was very low at 1.4. In determining whether a lesion was malignant or benign, precision rates were high even in small lesions, with, for example, 88% of lesions <= 1.0 cm being precisely identified. Results were excellent with regard to the ability to characterize the specific cell type when compared with surgical histopathology. The fact that the majority of proven specific cell types from needle biopsy specimens were the same as those finally proven by surgical pathology (80.0% of all biopsied lesions [88 of 110 lesions] and 84.6% of all lesions from which sufficient samples were obtained [88 of 104 lesions]) confirmed the high degree of reliability of the method under discussion using the Auto Surecut needle under CT fluoroscopic guidance to precisely determine the specific cell type.

From these results, it can be concluded that the Auto Surecut needle, which we used in this study, is at least equal, or might even be said to be superior, to previously reported cutting needles in the ability to evaluate lung nodules accurately and to characterize them specifically from CT scan-guided tissue-core lung biopsy specimens. This may be due to the fact that a larger specimen can be obtained with a needle of a given diameter compared to the modified Tru-Cut needle, and it has been shown17 that the number of biopsies obtaining no specimen was smaller compared to that of other modified Menghini-type needles. The fact that the rate of biopsy-induced complications, as shown in the present study, compared equally with that of previous research also demonstrates the safety of using this needle. In addition, we believe that the choice of real-time CT fluoroscopy as an adjunct to a series of biopsy procedures also may contribute to performing lung biopsies more safely, more precisely, and more conveniently, especially in maintaining high sensitivity for small lesions.

Received for publication June 14, 2002. Accepted for publication January 24, 2003.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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