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Percutaneous needle biopsy of lung nodules under CT fluoroscopic guidance with use of the "I-I device"

Departments of ¹ Radiology and ² General Thoracic Surgery, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-chyo, Kawaramachi-Hirokoji, Kamigyo, Kyoto, 602-8566, Japan

Correspondence: Rika Yoshimatsu, MD, Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-chyo, Kawaramachi-Hirokoji, Kamigyo, Kyoto, 602-8566, Japan. E-mail: rika442{at}koto.kpu-m.ac.jp

	Abstract

Top Abstract Introduction Subjects and method Results Discussion References

 
The aim of this study is to evaluate the feasibility and safety of CT fluoroscopic-guided needle biopsy with the use of the "I-I device", which was developed to assist in precisely advancing the needle while avoiding irradiation to the operator's hand. Using the "I-I device" under CT fluoroscopic guidance, 131 percutaneous needle lung biopsies were performed followed by histopathological evaluation. The final diagnosis was confirmed by independent surgical pathological findings or clinical follow-up. The rate of success in obtaining specimens adequate for histopathological analysis was 100% (131/131). For the 104 lesions that we were able to follow up, sensitivity, specificity and accuracy in diagnosing malignancy were 93.8%, 100% and 95.2%, respectively. In 51 lesions for which surgery was performed, the specific cell type was characterized in 98.0% (50/51; malignant, n = 38; benign, n = 12). The specific cell type was precisely diagnosed and confirmed after surgery in 36 malignant lesions and 8 benign lesions. Biopsy-induced complications were pneumothorax in 34.0% (44/131) and haemoptysis in 9.9% (13/131). None of the patients had serious complications. In conclusion, CT fluoroscopic-guided lung biopsy with use of the "I-I device" provides a high degree of diagnostic accuracy, allows specific characterization of lung nodules and can be performed safely.

	Introduction

Top Abstract Introduction Subjects and method Results Discussion References

 
CT scan-guided needle biopsy of lung nodules has become a well-established diagnostic technique [1]. The modalities commonly used for image-guided percutaneous needle biopsy include fluoroscopy [2], conventional CT [1, 3] and helical CT [3], the last one of which has become more widely used. CT fluoroscopy, which was developed most recently, has simplified the process and decreased procedure time [4–6]. However, direct irradiation to the physician's hand has been considered to be a disadvantage of this modality. Generally, surgical forceps [7, 8] or a special needle holder [9] have been used to hold the needle to avoid direct irradiation. However, problems are associated with this strategy. The physician does not receive sufficient tactile feedback from resistance of the needle and it is hard to apply subtle force. Also, precise needle placement is sometimes problematic because of the difficulty in keeping the needle within the tomographic plane. Recently, a new device called the "I-I device" (Hakko, Tokyo, Japan) became commercially available. This device helps to advance the biopsy needle precisely under CT fluoroscopic guidance as well as to reduce irradiation to the physician's hand. The purpose of this study was to evaluate the feasibility and safety of CT fluoroscopic-guided needle biopsy with the assistance of the I-I device.

	Subjects and method

Top Abstract Introduction Subjects and method Results Discussion References

 
Subjects
For 126 patients (71 men, 55 women; mean age 65.0 years; age range 29–89 years) who required percutaneous needle biopsies of the lung between March 2003 and April 2004 in our institution, we performed 131 consecutive percutaneous needle biopsies for 128 lung nodules using the I-I device under real-time CT fluoroscopic guidance. Among these 126 patients, 2 had 2 nodules, and biopsies for each lesion were performed on different days. In another three patients a repeated biopsy procedure was performed because the initial biopsy under CT fluoroscopic guidance was negative but histopathologically non-specific. Both fine-needle aspiration and core biopsy were performed in 26 procedures, while core biopsy alone was performed in 105 procedures. A 21-gauge Sonopsy needle (Hakko, Nagano, Japan) was used for all fine-needle aspirations. For core biopsies, either an 18- or 20-gauge Auto Surecut needle (Create Medics, Yokohama, Kanagawa, Japan) or an 18- or 20-gauge Monopty needle (Bard, Covington, GA, USA) was used. We selected a smaller needle in cases in which the nodule was adjacent to large vessels or the heart. The mean diameter of the lesions was 23.3±16.9 mm (± standard deviation (SD)) with a range of 3 to 110 mm (3–10 mm, n = 30; 11–20 mm, n = 52; 21–30 mm, n = 23; 31–110 mm, n = 26). The mean depth as measured from the pleural surface to the edge of the mass was 16.8±17.9 mm (±SD) (range, 0–80 mm).

I-I device
The I-I device is made of acrylate resin and consists of two columns joined parallel to each other (Figure 1a,b). One column holds the needle and accepts 16- to 21-gauge outer guide needles. The other column is used as a holder for guiding and positioning the needle that is inserted in the other column. The tip of the outer guide needle remains in the subcutaneous tissue, and the length of the holder can be adjusted to keep the needle trajectory in the tomographic plane, which is determined by referring to the standard laser marker of the CT gantry. Thus, this device allows the needle to be kept in the tomographic plane resulting in accurate and rapid needle placement. Furthermore, the use of the outer guide needle allows smooth and straightforward advancement of biopsy needles.

View larger version (45K): [in this window] [in a new window]   Figure 1. (a) Photograph of the I-I device. The column that holds the needle can accommodate 16- to 21-gauge outer guide needles (arrow). The length of the other column for holding the device can be adjusted by rotating the inner bar (arrowhead). (b) The biopsy needle mounted in the I-I device is placed on the patient. The tip of the outer guide needle remained in the subcutaneous tissue (small arrow), and the length of the holder is adjusted (arrowhead) to keep the needle trajectory in the tomographic plane, which is determined by referring to the standard laser marker of the CT gantry (large arrows). The needle is positioned on the standard laser marker (small arrowheads). Appropriate adjustment of the holder length enables the needle to be constantly kept in the tomographic plane for whichever direction the needle will be tilted (curved arrow).

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, the patient's 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 (n = 41), prone position (n = 64) or lateral position (n = 26).

The procedure was performed by one of three interventional radiologists who were experienced in CT scan-guided biopsy. A CT fluoroscopic imaging system was used for all CT scan-guided biopsy procedures (Figure 2). Details of CT fluoroscopy have been described elsewhere [4]. Imaging parameters during CT fluoroscopy included a CT beam width collimated to 3 mm, tube voltage with a 120 kilovolt peak, current of 30–50 mA, and scanning speed of 0.75 s per rotation (360°).

View larger version (126K): [in this window] [in a new window]   Figure 2. CT scan images of an 82-year-old woman with metastatic lung cancer from breast cancer. Real-time CT fluoroscopic scan with patient in the prone position shows that the biopsy needle attached to the I-I device is penetrating the lung nodule (arrowhead). The entire biopsy needle inserted in the outer guide needle of the I-I device (arrow) is kept precisely in the tomographic plane.

All biopsy procedures were performed under local anaesthesia. After the biopsy procedure, axial CT images were obtained during a single breath-hold through the level of the biopsy or, if necessary, through the whole chest using helical CT scanning to determine 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 intravenous catheter. When the pneumothorax did not decrease, or even increased despite manual aspiration, a chest tube was placed.

Specimens obtained by fine-needle aspiration were evaluated cytologically, and those obtained by core biopsy were evaluated histologically. All cytological and histological evaluations were performed by experienced chest cytopathologists. They were required not only to classify obtained specimens as positive or negative for malignancy but also to identify specific cell types such as adenocarcinoma, small cell carcinoma, etc., in cases of a malignant lesion, or in cases of a benign lesion to diagnose conditions such as hamartoma, tuberculosis, etc., if possible.

Investigated parameters
The following parameters were retrospectively investigated: (1) time required for each biopsy procedure; (2) number of punctures for each biopsy procedure; (3) technical success rate; (4) rate of success in obtaining sufficient samples for histopathological evaluation; (5) ability to determine whether the lesion was malignant or benign in cases in which independent surgical pathology or clinical follow-up could be obtained in addition to needle biopsy; (6) ability to characterize specific cell types, which was evaluated by comparing results of independent surgical pathology in cases in which surgical operation was performed (n = 51); and (7) complications.

	Results

Top Abstract Introduction Subjects and method Results Discussion References

 
The mean time required for biopsy procedures was 19.6±8.3 min (mean±SD; range, 8–49 min). We timed the entire period that the patient was on the CT scanner table; thus the time for emergency management in cases with biopsy-induced complications, such as immediate percutaneous manual aspiration for complicated pneumothorax, is included in this required time. Overall, 239 punctures were carried out in 131 procedures. The average number of punctures in a single biopsy procedure was 1.8±0.9 (mean±SD; range, 1–4).

In 238 (99%) of the 239 punctures, technical success was achieved. In the one case of technical failure, the diameter of the lesion was 7 mm and the depth from the pleural surface was 12 mm. Technical success was declared when it was confirmed that the target was hit or penetrated with the needle as shown on the CT fluoroscopic image.

Of 131 biopsy procedures, specimens adequate for histopathological evaluations were obtained in all 131 (100%). The biopsy was deemed inadequate if specimens collected contained only blood or normal lung cells.

In 104 of 131 lesions, the final diagnosis was obtained after needle biopsy by independent surgical pathology (n = 51) or clinical follow-up (n = 53). Clinical proof of a malignant lesion was accepted if the patient was treated for malignancy and the subsequent clinical course and response to therapy were appropriate. Clinical proof of a benign lesion was accepted if any of following three conditions were satisfied: (1) spontaneous resolution; (2) resolution after treatment for conditions other than cancer, such as antibiotic treatment; and (3) no change in lesion size for more than 12 months. Whether a lesion was malignant or benign was precisely diagnosed by the biopsy specimen in 99 of the 104 lesions (95.2%). All 75 lesions diagnosed as malignant on biopsy were proved to be malignant by surgical histopathology or clinical follow-up. 24 (82.8%) of 29 lesions diagnosed as benign by needle biopsy were confirmed to be benign. However, the remaining five were finally diagnosed as malignant (Table 1). The specific cell types of the five lesions diagnosed to be benign using needle biopsy and that conflicted with the final diagnoses were focal pneumonia (n = 2), organized pneumonia (n = 1), granuloma (n = 1) and no evidence of malignancy (n = 1). In summary, sensitivity, specificity and accuracy for diagnosis of malignant lesions were 93.8%, 100% and 95.2%, respectively.

	Discussion

Top Abstract Introduction Subjects and method Results Discussion References

 
In lung nodule biopsy under classic CT guidance (i.e. conventional or helical CT guidance), the success rates in obtaining sufficient samples for cytohistological evaluation and diagnostic accuracy have ranged from 80% to 100% [3, 11–22] and from 81% to 95%, respectively [12–17, 19, 21, 23–25]. However, classic CT has been limited by a lack of real-time visualization of target lesions, especially for small lesions, mediastinal lesions and in patients who are unable to cooperate with breath holding [4–6]. Few investigations of classic CT-guided lung biopsy have dealt with the correlation between lesion size and diagnostic ability. Li et al [24] reported that the diagnostic accuracy of CT-guided cytology with fine-needle aspiration was 74% for 27 small lesions (1.5 cm in diameter) and 96% for 70 lesions >1.5 cm in diameter, a difference that was statistically significant. Tsukada et al [15] utilizing automated needle biopsy for lung nodules under classic CT guidance also described a decrease in diagnostic accuracy in relation to decreases in lesion size. In their study, diagnostic accuracy according to lesion size was as follows: 50–100 mm, 100%; 31–50 mm, 93.3%; 21–30 mm, 86.7%; 11–20 mm, 78.9%; and 6–10 mm, 66.7%. Moreover, Ohno et al [25] noted that needle path length affected diagnostic accuracy. In a review of 162 patients who underwent percutaneous needle aspiration biopsy under classic CT guidance, the diagnostic accuracy for needle path length >40 mm was significantly lower than that 40 mm (>40 mm, 52.3%; 40 mm, 92.1%). In summary, these previous reports suggested that diagnostic ability of lung biopsy under classic CT guidance worsened as lesion size lessened and the needle path lengthened.

On the other hand, CT fluoroscopy, which was developed most recently to enable real-time visualization, might be able to resolve this problem. For small lesions, Yamagami et al [26], in a review of 110 percutaneous tissue core biopsies under CT fluoroscopic guidance, reported higher diagnostic accuracy (21–45 mm, 100%; 11–20 mm, 97.5%; and 3–10 mm, 88.0%) than non-CT fluoroscopic guidance.

In addition, usage of CT fluoroscopy in percutaneous needle biopsy simplified the process and decreased procedure time [4]. Katada et al [4] reported that biopsy of lung nodules under CT fluoroscopic guidance was performed successfully with a single puncture in 90% of cases, and the average number of punctures to gain access to the lesions was 1.1. Those results were superior to previous results for classic CT-guided biopsies (average number of punctures, 1.4–4) [13, 15, 19, 21]. Gianfelice et al [6] reported that results of a comparison between 190 consecutive patients who underwent a percutaneous lung biopsy under CT fluoroscopic guidance and 93 consecutive patients who underwent a classic CT-guided biopsy showed that the mean procedure time was significantly lower with the former method (27.56 min versus 43.17 min, p<0.0001; Welch unpaired t test).

However, direct exposure to radiation of the physician's hand is a serious problem with CT fluoroscopic-guided procedures. To avoid such exposure, the I-I device was developed to hold the needle [27–29]. Regarding percutaneous needle biopsy for lung nodules under CT fluoroscopic guidance using the I-I device, Irie et al [27] reported diagnostic accuracy of 90%, and that the biopsy procedures were completed within a single breath-hold in 58 (75%) of 77 evaluated subjects. The radiation dose to the physician's hand was 0.1 mSv s^–1 [27], whereas it was reported to be 1.14 mGy s^–1 in such biopsies without the needle holder [4]. Irie et al [27] also described that use of the I-I device enabled a rapid biopsy procedure, with mean CT fluoroscopy times and procedure times of 37 s and 23 min, respectively. These were less than in previous reports [4, 6] of CT fluoroscopic guidance procedures in which the I-I device was not used wherein CT fluoroscopy times and procedure times ranged from 41.55 seconds to 74 seconds and 27.56 min to 54 min, respectively.

In the present study, we examined more cases than did Irie et al [27]. The mean procedure time in this study was 19.6 min, which was less than in previous reports of needle biopsy for lung under CT fluoroscopic guidance [4, 6, 30] as well as that reported by Irie et al in which the I-I device was used. The ability to obtain adequate specimens and to diagnose malignant lesions in our study was at the high end in comparison with previous reports [3, 11–27, 30]. The diagnostic accuracy for small lesions was equal to that for large lesions; for example, 95.7% of lesions 1.0 cm were precisely diagnosed, a result that was superior to those in previous reports [13, 15, 24, 26]. Furthermore, when the depth from the pleural surface to the edge of the mass was considered, diagnostic ability was not affected, contrary to the report by Ohno et al [25] in which helical CT rather than CT fluoroscopy was used. These results suggest that use of the I-I device does not affect the precision of needle biopsy regardless of lesion size and depth. The frequency of biopsy-induced pneumothorax, which is the most common complication of CT-guided lung biopsy, in the present study was similar to that in previous reports [3, 13–15, 19, 21–27, 30] (ranging from 17.9% [3] to 54.3% [14]).

Undoubtedly, the purpose of lung biopsy is to differentiate malignant from benign lesions. Furthermore, determining the specific cell type is essential, especially to discern whether the lesion is small or non-small cell carcinoma of the lung or metastasis, because treatment is selected based on this information. Clarification of the specific cell type also may be necessary for benign lesions. Otherwise, for example, a diagnosis of simply "negative for malignancy" would indicate the necessity for long-term follow-up or biopsy with another procedure [14], because in some cases lesions not diagnosed according to specific cell type are found to be malignant on second biopsy or follow-up study [2]. Previous reports of CT-guided tissue-core biopsy of lung nodules [11, 12, 14–16, 26, 30] show that the specific cell type could be characterized in 60–99% of malignant lesions and 44–91% of benign lesions that were evaluated histologically. Results of the present study 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 were the same as those finally proven by surgical pathology (86.2% (44/51) of biopsied lesions for which surgery was performed) confirmed the high degree of reliability in precisely diagnosing the specific cell type of the method under discussion using the I-I device.

From the results of our study, it can be concluded that percutaneous lung biopsy employing the I-I device under CT fluoroscopic guidance is at least equal, or perhaps superior, to methods previously reported for accurate diagnosis of lung nodules and specific characterization of cell types from CT-guided tissue-core lung biopsy, especially for small and deeply located lesions. Furthermore, use of the I-I device enables us to perform lung biopsy more rapidly and more precisely while avoiding irradiation to the operator's hand.

Received for publication February 12, 2007. Revision received April 12, 2007. Accepted for publication April 25, 2007.

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