Photograph of the Easy Core Biopsy Device (Boston Scientific, Natick, Massachusetts), an automated core needle biopsy system.
Schematic diagram illustrating the action of the automatic core needle biopsy system. A, The needle is positioned against the mass and subsequently fired (action not shown); B, firing of the needle delivers the inner trocar of the needle into the mass; C, the outer cannula of the needle immediately follows the inner cannula; D, the needle is withdrawn from the mass; E, the outer cannula is withdrawn, and the specimen is removed for examination.
Diagram showing the proposed algorithm for the evaluation of head and neck masses. FNA indicates fine-needle aspiration.
Nyquist GG, Tom WD, Mui S. Automatic Core Needle BiopsyA Diagnostic Option for Head and Neck Masses. Arch Otolaryngol Head Neck Surg. 2008;134(2):184-189. doi:10.1001/archoto.2007.39
Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2008
To examine the role of core needle biopsy in the diagnosis of head and neck masses.
Prospective observational study.
The otolaryngology–head and neck surgery department outpatient clinic of a large managed care organization.
The study population comprised 40 consecutive patients referred for core needle biopsy of a cervicofacial lesion for which previous fine-needle aspiration biopsy had not provided the diagnosis.
Manually guided Delta Cut (Boston Scientific, Natick, Massachusetts)
core needle biopsy was performed on neck masses larger than 1.5 cm.
Main Outcome Measure
Diagnosis was indicated by core needle biopsy results without excisional biopsy.
A core needle biopsy specimen sufficient for diagnosis and treatment was obtained from 36 of the 40 patients (90%). In 22 patients, subsequent excisional biopsy or curative surgery was performed after core needle biopsy, and pathologic examination confirmed the diagnosis for 19
of these 22 patients (86%). For 12 of the remaining 14 patients (86%), core needle biopsy was successfully used to diagnose lymphoma. No complications resulted from the core needle biopsy.
For lesions that require immunohistochemical staining or that remain undiagnosed after fine-needle aspiration, use of core needle biopsy should be considered before excisional biopsy. Core needle biopsy is a safe, effective, time-efficient, inexpensive procedure that can be an important tool for diagnosing head and neck masses, especially when lymphoma is suspected.
Masses of the head and neck are described by a heterogeneous group of diagnoses reached by a number of evaluative processes. A thorough medical history and physical examination as well as laboratory tests and radiologic evaluation are important components of this process, but the definitive diagnosis usually requires an adequate biopsy specimen.
Fine-needle aspiration (FNA) is an easy, quick, inexpensive technique for diagnosing head and neck masses with a high degree of accuracy.1 However, a substantial number of masses remain undiagnosed after FNA because the sample was inadequate. In addition, diagnosis of some lesions requires immunohistochemical examination or analysis of the cell architecture. For these situations, several options are available, including repeated FNA, flow cytometry, radiologically guided core needle biopsy, or open biopsy.
We describe office-based use of an automatic core needle biopsy system, which incorporates a manually guided technique (similar to FNA) for sampling suspect head and neck masses. Among the patients in our study, either the attempt to diagnose the lesions by FNA failed or the lesion was suspected to be of a type for which additional tissue would be needed to obtain a diagnosis.
We conducted a prospective observational study of patients referred to the Head & Neck Surgery Department of the Kaiser Permanente San Francisco Medical Center, San Francisco, California, for core needle biopsy of an undiagnosed cervicofacial lesion. Patients were selected for core needle biopsy either after FNA failed to provide the diagnosis or if the medical history suggested the presence of a lesion that would be diagnosed most effectively with a tissue biopsy. Full institutional review board approval was obtained.
For automated core needle biopsy, we used the Easy Core Biopsy Device equipped with an 18-gauge Delta Cut needle (Boston Scientific, Natick, Massachusetts) (Figure 1). This biopsy system uses an automatic spring-loaded needle equipped with a retractable outer cannula and inner stylet. The handpiece has a safety switch, trigger, and thumb tabs to retract the cannula and stylet. After being positioned against the mass and then fired, the needle rapidly advances forward 2 cm, cutting a core of tissue 17
mm long. The needle system may be fired multiple times and is intended for single-patient use.
Core needle biopsy was performed after local injection of an anesthetic agent into the area surrounding the mass. A stab incision over the mass was then made using a scalpel with a No. 11 blade, allowing easy insertion of the long needle tip (Figure 2). To avoid contact with vascular structures, the needle was positioned at an angle (away from the carotid sheath for neck lesions), while the tip was positioned against the superficial surface of the mass. This system should not be used for lesions that are smaller than 2 cm and abut the carotid sheath. The trigger was then pulled, automatically advancing the needle into the mass. When the needle was removed, the biopsy specimen was retrieved by retracting the outer cannula only. The biopsy procedure was repeated for a total of 2 or 3 passes. Pressure was held over the biopsy site for 5 minutes before a bandage was placed, and the patient was discharged home.
Specimens were preserved in a standard formalin solution and processed by the pathology department for paraffin sectioning, and appropriate immunohistochemical staining was performed as needed. Imprint cytologic examination (touch preparation) to determine an adequate biopsy specimen or provide a preliminary diagnosis was not performed. Immediate review by a pathologist could be performed if one is readily available, and this may improve diagnostic rates. Additional tests, including open biopsy, were performed if needed to obtain the diagnosis.
Core needle biopsy of the cervical facial mass was performed for 40 consecutive patients (Table). The mean patient age was 55 years (range, 20-89 years), and 23
of the 40 patients were male. Lesions were located in the neck lymphatics (23 patients), salivary glands (13 patients), or thyroid (4 patients). The size of lesions ranged from 1.2 cm to 5.0 cm. No patients sustained neurologic or vascular injury during the core needle biopsy procedure, and no evidence of tumor “seeding” was observed.
In 37 patients, FNA had been performed initially and produced inconclusive results. For 15 of the 37 patients (41%), results of FNA were insufficient or nondiagnostic; results of FNA in the other 22 patients showed lymphocytes of unknown clinical significance (11
patients), poorly differentiated carcinoma (4 patients), squamous cells (2 patients), salivary tissue (2 patients), chronic inflammation (2 patients), and epithelial cells (1 patient).
Three patients were considered to be candidates for core needle biopsy instead of FNA for initial tissue sampling. Patient 1 had a recent history of breast cancer, and the presenting neck lesion was suspected to be metastatic breast adenocarcinoma. The oncologist requested a tissue sample, so receptor testing could be performed for both treatment and prognosis purposes. Patients 4 and 36 had a history of low-grade lymphoma and recurrence was suspected. Thus, immunohistochemical analysis was required for diagnosis, typing, and treatment.
In 36 of the 40 patients (90%) who had core needle biopsy, biopsy specimens were sufficient for diagnosis and for proceeding with treatment. Of the 40 patients, 22 had subsequent excisional biopsy or curative surgery after core needle biopsy; in 19 of these 22 patients (86%), pathologic examination confirmed the diagnosis. After core needle biopsy yielded inconclusive results suggestive of lymphoma, 2 of the remaining 3 patients (patients 5 and 18) had open biopsy that led to the ultimate diagnosis of lymphoma. In these 2 patients, pathologic assessment of the specimen was challenging because the mass was largely necrotic. In the third case, the nondiagnostic result of core needle biopsy raised suspicion of lymphoma after the patient (patient 38) had undergone both core needle biopsy and excisional biopsy. Moreover, that patient's final diagnosis, Kikuchi disease, was made only after outside consultation was obtained regarding diagnosis of the open biopsy specimen suggesting the difficulty in making this diagnosis. In 12 of 14 patients (86%), core needle biopsy was successfully used to diagnose lymphoma.
In 24 of the 40 patients (60%), the surgical course was altered as a result of core needle biopsy. In 18 patients, core needle biopsy was sufficient for diagnosis and for proceeding to medical treatment without need for open surgical biopsy. In 4 patients, results of core needle biopsy indicated the need for additional examination and surgery. In 1 patient, core needle biopsy of a neck mass showed metastatic papillary thyroid carcinoma, and this result prompted neck dissection as well as total thyroidectomy of a thyroid gland that had appeared normal. In another patient, core needle biopsy of a parotid lesion showed melanoma that was initially diagnosed by FNA as poorly differentiated carcinoma; the finding of melanoma prompted preoperative positron emission tomographic scanning, which detected the primary tumor in the ipsilateral eyebrow. This detection allowed additional, definitive surgical treatment of the primary site as well as preoperative counseling for the patient.
Because FNA can be performed quickly and cost efficiently with minimal discomfort to patients, this procedure is widely accepted as the first step in examining most head and neck masses. Indeed, for most patients, FNA provides the diagnosis and leads to appropriate treatment.1 However, FNA has important limitations. Because the process of making cytologic smears of the aspirate precludes histologic inspection of cell architecture, complete immunohistochemical analysis of the aspirate is not possible. Use of FNA to diagnose lymphoma or for typing undifferentiated carcinoma therefore presents a challenge.
For lesions that FNA fails to diagnose or for which FNA may be an inappropriate diagnostic tool, several options are available. Head and neck surgeons frequently choose open biopsy as the next step toward reaching the diagnosis. The advantage of open biopsy is that it nearly always provides a tissue sample sufficient for diagnosis. This advantage is countered, however, by several disadvantages. Because open biopsy is highly invasive, the procedure places patients at increased risk of infection, damage to nervous and vascular structures, and unfavorable scarring. Open biopsy also adds costs (because the procedure requires use of a surgical suite), delays diagnosis and treatment (because the surgical suite must be scheduled in advance), and carries the risks inherent in sedation or general anesthesia. Moreover, open biopsy carries a known risk of seeding tumor2 and can violate a future surgical field, making definitive surgical treatment more difficult.
Flow cytometry has been advocated as an easily performed procedure that can augment FNA, especially for identifying non-Hodgkin lymphoma.3- 7 However, flow cytometry is limited insofar as it is not a reliable tool for diagnosing Hodgkin disease or low-grade lymphoma.4- 6 If a physician suspects a lymphoma, then a piece of the core needle specimen could be preserved in the liquid medium used for flow cytometry and the remainder placed in formalin solution for permanent sectioning.
Use of radiologic (image-guided) core biopsy is well described in the literature. Studies using computed tomography, magnetic resonance imaging, or ultrasound guidance with automatic and manually operated needle systems have reported diagnosis rates ranging from 90% to 100%.8- 13 With radiologic guidance, the surgeon can precisely locate a lesion while safely guiding needle placement to avoid contact with major vessels. The procedure also provides additional radiologic information about the lesion. A disadvantage of the radiologically guided procedure is the logistical delay inherent in scheduling the assistance of a radiologist. Additional cost is also incurred by use of ultrasonography, computed tomography, or magnetic resonance imaging. Moreover, many radiologists are using large 12-, 14-, or 16-gauge needles14 that cause increased local trauma.
Core needle biopsy without image-based guidance is not a new concept. Manually controlled needles equipped with cutting trocars have been used as a first step in diagnosing thyroid lesions and head and neck lesions.15- 18 Two of these studies were performed in the outpatient setting, and no major neurovascular complications were reported in any report. Although such use of core needle biopsy has yielded a diagnostic rate ranging from 79%15 to 83%,18 the role of manually guided core needle biopsy in relation to the now predominant use of FNA has not been elucidated.
Few published studies have described experience with non–image-guided, automated core biopsy systems used for diagnosing head and neck masses. In a report describing manual and (often laparoscopic) use of the ASAP Automated Biopsy System (Boston Scientific) for investigating persistent or recurrent oral or laryngeal carcinoma, Samy and Scher19 advocated the use of this biopsy system because it provides relatively atraumatic sampling and predetermined depth of biopsy.
The present report on the diagnosis of head and neck lymphoma showed that core needle biopsy led to the diagnosis of lymphoma in 12 of 14 biopsy specimens. Our experience using the Easy Core Biopsy Device for manually guided automatic core needle biopsy was therefore favorable and had several logistic advantages: it provides ease of use (a feature that is absent in some hand-operated core biopsy needles), reliable extraction of high-quality histologic specimens, convenience (because it can be used in the office), timeliness (because it avoids the delay necessarily imposed by scheduling additional appointments or use of a surgical suite), and relatively low cost (the No. 11 scalpel blade and biopsy needle system cost approximately US $25-$44). In addition, immunohistochemical staining is a standard technique used to diagnose, type, and develop treatment strategies for lymphoma and undifferentiated cancers. Preserving core needle biopsy specimens in formalin allowed for the necessary tests (including immunohistochemistry)
to be performed. The majority, but not all, of lymphomas can be diagnosed based on immunohistochemical and morphological features. A sample of tissue could also be separated from the specimen and sent for flow cytometry. It would be useful to consult with the pathologist beforehand to determine how the tissue should be preserved to optimize diagnostic rates at individual facilities.
Manually guided core needle biopsy, however, has potential disadvantages. Surgical skill is needed for proper needle placement. Improper placement of the needle can result in a lower yield, as shown by studies comparing ultrasound-based vs manual guidance in FNA.20,21 Then again, this technique could obviously be extrapolated for use in office-based settings where an ultrasound is used by an otolaryngologist. Because contact with blood vessels also must be avoided, the needle tip should be directed away from the carotid sheath, and core needle biopsy should not be used for lesions that are smaller than 2 cm and abut the carotid sheath. Our experience has also shown that biopsy may be more difficult for small lesions (<1.5 cm) or for lesions that contain a necrotic or cystic component. The size of the lesion and its large necrotic component explains three-fourths of our inconclusive core needle biopsy results. While the needle may advance a few millimeters past a 1.5-cm mass, this is not harmful as long as a major nerve or vessel is not damaged. Passes outside small lesions occur frequently during FNA without complication. Finally, manually guided core needle biopsy should not be used for nonpalpable lesions.
Although we did not incur a case of needle tract seeding in our series, another potential disadvantage of large-bore needle biopsy systems is the increased incidence of cancer seeding. A large review of 63 108 abdominal FNA biopsies revealed only 3 occurrences of needle tract seeding (indicating an incidence of 1 in every 20 000, or 0.005%).22 The incidence of seeding after core needle biopsy is certainly higher, varies by anatomic location, fluctuates with needle size, and depends on the type of malignancy and treatment. At one end of the spectrum, the incidence of pleural recurrence after core needle biopsy of lung cancer is 8.6%.23 Large-bore needle biopsy of the breast is one of the most commonly implemented uses of this technique, and incidences of seeding vary from 2% to 5% after treatment.24,25 On the other hand, the seeding rate was reported at 1% for prostate cancer after biopsy with a 14-gauge needle.26 The true incidence of seeding after core needle biopsy of the cornucopia of malignant head and neck lesions is yet to be determined. One would expect a much lower incidence of seeding after core needle biopsy of a lymphoma vs a squamous cell carcinoma. It is likely to be less than or equivalent to open biopsy when using an 18-gauge needle. One treatment strategy that head and neck surgeons should consider is excision of the needle tract site at the time of definitive surgery and/or inclusion of the biopsy site in the radiation field.
Nonetheless, we believe that head and neck surgeons—who routinely perform needle aspiration—possess the skill, experience, and discretion to perform core needle biopsy accurately and safely for most neck lesions. This belief is confirmed by our 90% overall rate of obtaining the diagnosis without encountering procedure-related complications. We do not extrapolate this recommendation to physicians who use an automatic core needle biopsy system in other anatomic locations or to physicians who are not thoroughly trained in head and neck surgical procedures.
Manually guided core needle biopsy is now a pivotal component of examining cervicofacial masses in the algorithm currently used by head and neck surgeons at our medical center (Figure 3). For most lesions, FNA is the first diagnostic step, usually followed by core needle biopsy. Manual guidance is used most commonly, but image-based guidance is considered when appropriate. Flow cytometry is used to supplement core needle biopsy when lymphoma is suspected. Open biopsy is reserved for cases for which other techniques are suboptimal alternatives.
In conclusion, manually guided core needle biopsy using an automatic needle system can be done confidently by experienced head and neck surgeons in an outpatient clinic setting. At minimal cost and with minimal morbidity, this procedure can safely and reliably lead to an accurate diagnosis and thus guide further medical and surgical therapy while avoiding unnecessary or harmful surgery. Manually guided core needle biopsy using an automatic needle system should therefore be considered an integral component of examining head and neck masses. To our knowledge, this report is the first to document the utility of core needle biopsy for diagnosing lymphoma of the head and neck.
Correspondence: Gurston G. Nyquist, MD, c/o Stanley Mui, MD, Department of Head and Neck Surgery, Kaiser Permanente Medical Center, 450 Sixth Ave, Second Floor, San Francisco, CA 94118 (email@example.com).
Submitted for Publication: October 6, 2006; final revision received June 22, 2007; accepted July 8, 2007.
Author Contributions: Dr Nyquist had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Nyquist, Tom, and Mui. Acquisition of data: Nyquist, Tom, and Mui. Analysis and interpretation of data: Nyquist, Tom, and Mui. Drafting of the manuscript: Nyquist, Tom, and Mui. Critical revision of the manuscript for important intellectual content: Nyquist, Tom, and Mui. Statistical analysis: Nyquist and Tom. Administrative, technical, and material support: Nyquist, Tom, and Mui. Study supervision: Nyquist, Tom, and Mui.
Financial Disclosure: None reported.
Previous Presentation: This study was presented as a poster at the Triologic Society Middle/Western Combined Meeting; February 2-5, 2006; San Diego, California; and won second prize for poster presentation.
Additional Contributions: Editorial assistance was provided by the Medical Editing Service of The Permanente Medical Group Physician Education and Development Department.
Additional Information: Dr Nyquist was a third-year resident, Head and Neck Surgery Residency Program, Kaiser Permanente Medical Center, Oakland, California, when the work was completed. Dr Tom was a fifth-year resident, Head and Neck Surgery Residency Program, Kaiser Permanente Medical Center, Oakland, California, when the work was completed.