Abstract
Tru-cut (core needle) biopsy has many advantages over open biopsy. It is quick and easy to perform, may be carried out in the outpatient department, avoids incision through previously irradiated skin and has few complications. The purpose of this study is to compare the two available biopsy techniques that are Tru-cut biopsy and incisional biopsy in achieving prompt diagnosis of maxillofacial pathology. A prospective study was conducted in 25 patients reported to our department. The Tru-cut biopsy was performed by using 14 gauge disposable Tru-cut biopsy needles (Baxter, made in the USA) by means of two successive insertions with different angulations of the needle into the core of the lesion followed by incisional biopsy. The diagnostic criteria which were evaluated include: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy. Tru-cut biopsy had sensitivity of 68.42%; specificity of 83.33%; PPV of 92.86%; NPV of 45.45% with accuracy rate of 72%. The Tru-cut biopsy method was evaluated as a very helpful method for prompt diagnosis of maxillofacial pathology since it is practical to perform, causes minimum trauma to the tissue, decreases the metastatic risk of malignant lesions during the procedure and relatively free from complications.
Keywords: Tru-cut needle, Core needle, Biopsy, Maxillofacial pathology
Introduction
The word Biopsy is derived from Greek. Bios means life and opsis means vision which implies an examination of tissue removed surgically. French dermatologist Earnest Besnier coined the term “biopsy” in 1879 [1]. Biopsy is the removal of tissue from a living patient for macroscopic examination, microscopic analysis, chemical analysis or a combination of the above [2]. Although the clinician with experience can make diagnosis of many lesions clinically, such a diagnosis is generally only a provisional one, dependent upon the final report on the tissue specimen by pathologist. The use of biopsy is not restricted to the diagnosis of tumors, but is invaluable in determining the nature of any unusual lesion. The ideal biopsy obtains sufficient tissue for accurate histopathological interpretation while causing as little trauma as possible [2].
Although an open biopsy can yield large amounts of tumor for histological evaluation, it is more likely to be complicated by bleeding, hematoma formation, tumor cell spillage and infection [2]. Tru-cut biopsy provides histologic study of core tissue. It is a very simple procedure wherein a needle with a gap near its tip is passed into the lesion which needs to be biopsied. A surrounding sheath with a cutting tip is passed down the needle. The sheath cuts a specimen corresponding to the gap in the needle. The needle and sheath, with the specimen, are then removed from the patient [3].
The Tru-cut biopsy needle can give core tissue sample as against to, just cells acquired through FNAC. This can definitely provide more definite and accurate diagnosis. The use of Tru-cut biopsy in the head and neck region is predominantly indicated in lesions involving the salivary gland, thyroid, lymph node as well as both benign and malignant tumors of the soft tissue [4]. Tru-cut biopsy is quick and easy to perform and has an advantage over incisional biopsy to provide accurate diagnosis. As there are both advantages and disadvantages seen in incisional biopsy as well as Tru-cut biopsy techniques, there is a need to analyze and evaluate comparing the above two techniques, and hence this study.
The purpose of this study is to compare the two available biopsy techniques that are Tru-cut biopsy and incisional biopsy in achieving prompt diagnosis of maxillofacial pathology and to determine the efficacy, safety and accuracy of Tru-cut biopsy in diagnosis of maxillofacial pathology along with evaluating the diagnostic usefulness of further histopathological details obtained with Tru-cut biopsy, and its effect on preoperative planning of surgical treatment.
Materials and Methods
A total of 25 patients were included in the study. The selected patients consisted of 9 females and 16 males, age ranging from 15 to 80 years. The pathologic conditions included in this study are benign and malignant tumors, soft tissue swelling, ulcers, etc. Patients were subjected to a thorough evaluation of their history, clinical examinations, blood investigations and radiographs.
Inclusion criteria:
Pathology in relation to maxillofacial region.
Exclusion criteria:
Vascular tumors like Hemangioma, Lymphangioma, Angiosarcoma, etc.
Individuals with cardiac disease, uncontrolled diabetes and hypertension.
Dangerous sites, e.g., vital structures like region near the eye, major vessels and nerve.
Unsuitable patients like very nervous, low pain threshold, on anticoagulation therapy and bleeding disorder.
14 Gauge Disposable Tru-Cut Biopsy Needle (Baxter, Made in the USA)
The Tru-cut biopsy needle consists of outer cannula (sheath) and inner trocar (needle) with an angled and sharp tip. The inner trocar has sample notch of 20 mm × 2.1 mm for holding tissue specimen from the lesion (Fig. 1).
Fig. 1.
Tru-cut Biopsy needle
Surgical Techniques
The Tru-cut biopsy was performed by using 14 gauge disposable Tru-cut biopsy needle (Baxter, made in the USA) by means of two successive insertions with different angulations of the needle into the core of the lesion.
After positioning the patient for disinfection, we used Savlon + Betadine over skin and Betadine + normal saline irrigation for intraoral mucosa. Local anesthetic (2% lignocaine + 1:80,000 adrenaline) injected; not in the immediate vicinity of the lesion and we have given nerve block whenever possible. Fingers of the left hand were used to fix the lesion. Thereafter, the point of insertion was chosen. This will usually be in the center of the site of the lesion in our study. The Tru-cut biopsy needle was grasped and pushed along with the sheath into the lesion. After hearing and feeling the click as the sheath reaches the end of the needle, the Tru-cut biopsy needle is withdrawn from the specimen and carefully inspected for quantity. If the specimen is inadequate, the procedure will be repeated. A Gauze swab was placed on the wound to control bleeding following withdrawal of the Tru-cut biopsy needle (Fig. 2).
Fig. 2.
Tru-cut Biopsy needle with specimen
The material obtained from Tru-cut biopsy needle was fixed in 10% formalin. The quantity and quality of the material obtained were judged immediately after immersion of the specimen in the fixative solution. For, e.g., If the specimen sinks in the fixative, it is likely to be tumor and if the specimen floats, it is likely to be fat suggesting a need to obtain a repeat biopsy (Fig. 3).
Fig. 3.
Tru-cut Biopsy Specimen in formalin
The incisional biopsy was performed by no.15 BP (Bard Parker) blade and handle. Biopsy site was selected in an area that shows complete tissue changes like in areas where the lesion extends into normal tissue at the base or margin (or both). Biopsy was taken as a deep, narrow specimen rather than a broad, shallow one so that it easy to get primary closure after the procedure. The specimen obtained was fixed with 10% formalin.
After labeling both specimen bottles were sent for histopathological evaluation. 20 out of 25 patients subsequently underwent open surgical excisional biopsy after the Tru-cut and incisional biopsy reports were obtained. The remaining 5 patients out of the overall 25 patients in the study were subjected to Tru-cut biopsy as well as incisional biopsy and since these 5 patients had extensive lesion they were declared as inoperable carcinoma.
Results
A total of 25 patients were included in the study in which 16 were males and 9 were female. Age of the patients ranged from 7 to 80 years with mean age of 45 ± 19.47 years. Sites of the lesion in the maxillofacial region were divided into 6 broad categories depending on origin of the lesion: Palate—2 cases; Tongue and Floor of Mouth—6 cases; Upper Gingivo-Buccal Sulcus—4 cases; Lower Gingivo-Buccal Sulcus—9 cases; Buccal Mucosa—2 cases; and Lip—2 cases. Size of the lesions was ranging from 0.5 to 35 cm2 with mean of 10.90 ± 8.23 cm.
The diagnosis obtained with Tru-cut biopsy and incisional biopsy techniques is presented in Table 1. Two cases in which both Tru-cut and incisional biopsy techniques failed to give a correlative diagnosis usually acquired through an excisional biopsy. The Tru-cut as well as incisional biopsy of the 1st case was reported as benign nerve sheath tumor and normal (No Malignancy), respectively, whereas Excisional biopsy reported as low-grade fibromyxoid sarcoma. In the 2nd case, Tru-cut as well as incisional biopsy reported as Basaloid Salivary gland tumor whereas Excisional biopsy reported as Ewing’s Sarcoma.
Fig. 4.
a Tru-cut Biopsy photo micro graph b Incisional Biopsy micro graph
Table 1.
Distribution of diagnosis
| No. | Age/sex of the patient | Site | Size (cm2) (Approx.) | Tru-cut | Incisional | Excisional |
|---|---|---|---|---|---|---|
| 1 | 16 years/F | Left side of palate | 3 × 4 | Pleomorphic adenoma (Fig. 4a) | Pleomorphic adenoma (Fig. 4b) | Pleomorphic adenoma |
| 2 | 45 years/F | Right lateral border of tongue | 3 × 3 | Dysplasia of tongue | Infiltrating well-differentiated squamous cell carcinoma of tongue | Squamous cell carcinoma of tongue |
| 3 | 17 years/M | Upper left gingivo-buccal sulcus | 5 × 3 | Organizing inflammatory lesion | Organizing inflammatory lesion | Organizing inflammatory lesion |
| 4 | 27 years/M | Right side of tongue | 1.5 × 1.5 | Inconclusive | Inconclusive | Neurofibroma in relation to right dorsal surface of tongue |
| 5 | 22 years/M | Upper left gingivo-buccal sulcus | 3 × 3 | Chronic inflammatory lesion suggestive of sinusitis | Chronic inflammatory lesion suggestive of sinusitis | Chronic nonspecific sinusitis |
| 6 | 7 years/M | Right side of tongue | 2 × 2 | Inconclusive | Inconclusive | Inconclusive |
| 7 | 65 years/M | Left lower gingivo-buccal sulcus | 4 × 3 | Severe dysplasia | Infiltrating squamous cell carcinoma | – |
| 8 | 55 years/F | Left lower Gingivo-Buccal sulcus | 4 × 1 | Verrucous carcinoma with infiltration | (1) Verrucous carcinoma (2) moderate dysplasia | Verrucous carcinoma with infiltration |
| 9 | 58 years/M | Right side of lower lip | 2.5 × 1 | Inconclusive | Inconclusive | Verrucous carcinoma |
| 10 | 60 years/M | Left lower Gingivo-Buccal sulcus | 7 × 4 | Moderately differentiated squamous cell carcinoma | Moderately differentiated squamous cell carcinoma | – |
| 11 | 60 years/M | Left ventral surface of tongue and floor of mouth | 1 × 0.5 | Normal (no malignancy) | Normal (no malignancy) | Normal (no malignancy) |
| 12 | 49 years/M | Left Buccal Mucosa | 4 × 3 | Caseating granulomatous inflammation suggestive of Tuberculosis | Caseating granulomatous inflammation suggestive of Tuberculosis | – |
| 13 | 15 years/M | Upper left gingivo-buccal sulcus | 3 × 3 | Inconclusive | Fibrous dysplasia of left maxilla | Fibrous dysplasia of left maxilla |
| 14 | 60 years/M | Right lower gingivo-buccal sulcus | 3 × 2.5 | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma | – |
| 15 | 35 years/M | Left lower alveolus and floor of mouth | 6 × 2.5 | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma |
| 16 | 60 years/M | Right lower Gingivo-Buccal sulcus | 0.8 × 1 | Skeletal muscles | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma |
| 17 | 70 years/M | Left side of palate | 5 × 7 | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma | – |
| 18 | 65 years/F | Right lower gingivo-buccal sulcus | 2 × 6 | Focal severe dysplasia | Focal severe dysplasia/moderate papillary squamous dysplasia | Noninvasive papillary carcinoma in situ |
| 19 | 35 years/M | Left lower gingivo-buccal sulcus | 4 × 4 | Benign nerve sheath tumor | Normal mucosa (No malignancy) | Low-grade fibromyxoid sarcoma |
| 20 | 80 years/F | Right side of lower lip | 2 × 2 | Skeletal muscle bundles | Squamous cell carcinoma with microinvasion | Infiltrating squamous cell carcinoma-Lip |
| 21 | 54 years/F | Upper right gingivo-buccal sulcus | 5 × 3 | Ulceroinflammatory lesion | Ulceroinflammatory lesion | Ulceroinflammatory lesion |
| 22 | 36 years/F | Left lower gingivo-buccal sulcus | 5 × 4 | Chronic nonspecific inflammatory lesion | Chronic nonspecific inflammatory lesion | Chronic nonspecific inflammatory lesion |
| 23 | 46 years/M | Left buccal mucosa | 2 × 2 | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma | Infiltrating squamous cell carcinoma |
| 24 | 50 years/F | Right lateral border of the tongue | 3 × 3 | No malignancy | Well-differentiated squamous cell carcinoma | Well-differentiated squamous cell carcinoma |
| 25 | 38 years/F | Left lower gingivo-buccal sulcus | 5 × 5 | Basaloid squamous cell carcinoma/basaloid salivary gland tumor | Basaloid squamous cell carcinoma/basaloid salivary gland tumor | Ewing sarcoma |
All statistical analysis was done using IBM SPSS Statistic software version 16 (IBM Corporation, Armonk, New York, USA).
The diagnostic criteria which were evaluated include: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy. Tru-cut biopsy had sensitivity of 68.42% (with 95% CI 43.46%–87.35%); specificity of 83.33% (with 95% CI 36.10%–97.24%); PPV of 92.86% (with 95% CI 66.06%–98.81%); NPV of 45.45% (with 95% CI 16.62%–76.50%) with accuracy rate of 72% (Table 2).
Table 2.
Diagnostic tests
| Diagnostic criteria | Percent | 95% CI |
|---|---|---|
| Sensitivity | 68.42% | 43.46%–87.35% |
| Specificity | 83.33% | 36.10%–97.24% |
| Positive predictive value | 92.86% | 66.06%–98.81% |
| Negative predictive value | 45.45% | 16.62%–76.50% |
| Accuracy | 72% | – |
Phi and Creamers correlation test was employed to assess the correlations between site, size and two biopsy techniques which shows strong correlation (creamers V value is 0.5) of Tru-cut biopsy technique with site of the lesion and weak correlation (creamers V value is 0.2) with size of the lesion.
Only 2 out of 25 (8%) patients had minor complications of bleeding which requires the use of the cautery and sutures to control the bleed. These two specific cases showed final diagnosis of Chronic Nonspecific Inflammatory Lesion and Ewing’s Sarcoma.
Discussion
Histopathological examinations are the most definitive methods in diagnosing the type, characteristic and prognosis of a pathologic lesion [2]. Open biopsy is considered as the gold standard for obtaining diagnostic tissue. However, open biopsy may be difficult to perform when accessibility is less and hazardous to the patient. Furthermore, open biopsy is associated with potential complications, such as tumor spread, infection, bleeding and wound breakdown [5]. Studies have also shown that poorly planned biopsy incisions can compromise subsequent definitive surgical approaches, often leading to less appropriate treatment choices and adverse patient outcome [6]. A biopsy is considered as successful only when diagnostic target tissue is obtained. Many pathologists believe that for histologic study, core tissue is more useful by Tru-cut biopsy needle [7].
Recently, needle biopsy became the recommended procedure at a number of medical centers, mostly because of the relative ease, safety and cost-effectiveness. Tru-cut needle biopsy provides a sample with preserved architecture, allowing comprehensive histologic evaluation including immunohistochemistry [8]. It can be performed easily as an outpatient procedure [3]. Patient requires no particular preparation other than careful explanation of the proposed procedure.
According to published reports, Tru-cut biopsy has advantages over open biopsy in that this technique is less painful and result in fewer complications. Tru-cut biopsy is a valuable diagnostic aid in the management of patients with head and neck lesions. However, accuracy rates of needle biopsy have reported to be 61–96%, which is less than that of open biopsy [9]. Theoretically, the lessened accuracy is to be expected because of the lower possibility of attaining the exact pathologic site with a needle and the small amount of tissue that can be retrieved by this technique. Joshi et al. [6] reported that Tru-cut biopsy can be performed even in less specialized centers.
In recent years, percutaneous image-guided Tru-cut biopsy has gained widespread popularity for tissue sampling particularly of deep-seated masses. Despite the advantages of Tru-cut biopsy, only a few studies have discussed its application for diagnostic purpose in maxillofacial pathology.
Compared to open biopsy, Tru-cut biopsy is less invasive, causes fewer complications and less expensive. Bleeding from the puncture site can be easily controlled by simple pressure application.
Yamashita et al. [7] reported that diagnostic target tissues obtained in 15 out of 16 cases and showed 88% accuracy rate. Ayhan et al. [2] showed 37 of the 40 samples were adequate for diagnosis and 3 were inadequate and success rate of open biopsy 92.5%, Tru-cut biopsy 55% and that of fine needle biopsy was 42.5%.
The literature about Tru-cut biopsy in the maxillofacial region is sparse [2, 7, 10–15]. However, numerous Tru-cut biopsy studies are available in lesions of the breast, liver, prostate, abdominal and pelvic tumors, tumors of the long bone, soft tissue tumors, etc. [3, 5, 8, 9, 16–24].
The presence of a circumscribed mass or diffuse swelling of a salivary gland can represent a major diagnostic and therapeutic challenge. Despite the small size and superficial location of many salivary gland lesions especially in the parotid glands, surgical resection is virtually impossible under local anesthesia because the presence of facial nerve cannot be monitored. Open biopsy is no longer justified because of the high risk of tumor seeding, facial nerve injury, facial scarring and fistula formation [10]. Tru-cut biopsy is very helpful tool in such lesions although we did not come across such lesions in our study.
Other authors have used ultrasound, CT scan, fluoroscopy and even MRI to guide the needle to the correct location to improve the accuracy of Tru-cut biopsy but there is no evidence of their advantage [6]. The major concern regarding Tru-cut biopsy is that it provides a limited sample and small tissue cores, in which the histologic morphology may not be appreciable [20]. Another disadvantage of the Tru-cut biopsy is that the material may be insufficient for other examinations such as electron microscopy, cytogenetics and tissue banking [9].
No major complication has been reported in the literature after performing Tru-cut biopsy. Schmidt RL et al. reported overall rate of hematomas 1.7% (7 of 403 cases) [15]. Complications of Tru-cut biopsy also include infections and there have been reports of seeding of malignant tumors. Recent studies have also reported the occurrence of vascular injury after core needle biopsy, the larger the needle size, greater is the potential for nerve injury [14]. Bearcroft et al. performed cutting needle biopsies of the neck using 16- and 18-gauge needles and stated that although seeding was a possibility with this technique, the exact incidence was unknown. Bearcroft also stated that seeding remains an unlikely event and did not consider it to be a contraindication to performing the procedure [7].
The Tru-cut biopsy method was evaluated as a very helpful method for prompt diagnosis of maxillofacial pathology since it is practical to perform, causes minimum trauma to the tissue, decreases the metastatic risk of malignant lesions during the procedure and relatively free from complications. It is safe and effective procedure if performed by team of Clinician and skilled Pathologist who are able to handle the relatively small samples. The adequacy and accuracy of Tru-cut biopsy are mainly influenced by the site of biopsy and its approach. New studies on this method especially with guided Tru-cut biopsy and biopsy with automated core needle would improve the technique to higher success rates and promote the method as the primary choice in routine practice.
Compliance with Ethical Standards
Conflict of interest
On behalf of all co-authors, the corresponding author declares that they have no conflict of interest. The copy of the signed form is attached separately.
Research Involving Human Participants and/or Animals
All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board of Bapuji Dental College and Hospital, Davangere, Karnataka and with the 1964 Helsinki declaration and its later amendments. Ethical Approval Letter by the Institutional Review Board is attached separately.
Informed Consent
Written consent is obtained from all patients involved in this study after explaining surgical procedures and its complications in detail. Except for age and sex which are necessary for this study, no other personal information of the patients was revealed in the script. Example of informed consent which is involved in this study is attached separately.
Footnotes
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