A Comprehensive Assessment of the Harms of Fine-Needle Aspiration Biopsy for Thyroid Nodules: A Systematic Review.

BACKGRUOUND: There have concerns related with the potential harms of fine-needle aspiration biopsy (FNAB). We aimed to summarize the clinical complications and evaluate the safety of FNAB. METHODS: Studies related with the harms of FNAB were searched on MEDLINE, Embase, Cochrane library, and KoreaMed from 2012 to 2022. Also, studies reviewed in the previous systematic reviews were evaluated. Included clinical complications were postprocedural pain, bleeding events, neurological symptoms, tracheal puncture, infections, post-FNAB thyrotoxicosis, and needle tract implantation of thyroid cancers. RESULTS: Twenty-three cohort studies were included in this review. Nine studies which were related with FNAB-related pain showed that most of the subjects had no or mild discomfort. The 0% to 6.4% of the patients had hematoma or hemorrhage after FNAB, according to 15 studies. Vasovagal reaction, vocal cord palsy, and tracheal puncture have rarely described in the included studies. Needle tract implantation of thyroid malignancies was described in three studies reporting 0.02% to 0.19% of the incidence rate. CONCLUSION: FNAB is considered to be a safe diagnostic procedure with rare complications, which are mainly minor events. Thorough assessement of the patients' medical condition when deciding to perform FNABs would be advisable to lower potential complications.

Assessment of the risk of disease transmission during fine-needle aspiration cytology under ultrasound guidance by visualization of droplet and aerosol formation.

PURPOSE: Fine-needle aspiration cytology (FNAC) under ultrasound guidance is clinically useful, but there is a risk of spreading infection by generating droplets of contaminated fluids during the procedure. Risk assessment to better control infection remains to be established. The aim of this study was to estimate infection risks during FNAC by visualization of droplet production and deposition using a simulation model. METHODS: The simulation comprised a puncture needle, a device for holding the needle, and a fluid specimen containing fluorescent particles as a model. Simulating each step of FNAC (removal of the inner and outer cylinder and transferring the specimen onto a glass slide), the generation and deposition of droplets were visualized using a laser. RESULTS: After removal of the inner cylinder, an aerosol of droplets in the air surrounding the needle was observed. After removal of the outer cylinder, several large droplets precipitating onto the circumjacent surface were observed. From the beginning of transferring the specimen, a large amount of sizeable droplets first moving away and then precipitating was observed, followed by the production of a cluster of fine droplets drifting and spreading through the air. CONCLUSIONS: Here, the generation of droplets at each step of FNAC, precipitation of large droplets onto the circumjacent surface, and drifting and spreading through the air of fine droplets was visualized. These results emphasize the need for precautions to prevent the transmission of infectious agents during FNAC.

Exploratory cost-effectiveness model of electromagnetic navigation bronchoscopy (ENB) compared with CT-guided biopsy (TTNA) for diagnosis of malignant indeterminate peripheral pulmonary nodules.

INTRODUCTION: Lung cancer is accountable for 35 000 deaths annually, and prognosis is improved when the cancer is diagnosed early. CT-guided biopsy (transthoracic needle aspiration, TTNA) and electromagnetic navigation bronchoscopy (ENB) can be used to investigate indeterminate pulmonary nodules if the patient is unfit for surgery. However, there is a paucity of clinical and health economic evidence that directly compares ENB with TTNA in this population group. This cost-effectiveness study aimed to explore potential scenarios whereby ENB may be considered cost-effective when compared with TTNA. METHODS: A cohort decision analytic model was developed using a UK National Health Service perspective. ENB was assumed to have equal sensitivity to TTNA at 82%. Lifetime costs and quality-adjusted life-year (QALY) gain were calculated to estimate the net monetary benefit at a £20 000 per QALY threshold. Sensitivity analyses were used to explore scenarios where ENB could be considered a cost-effective intervention. RESULTS: Under the assumption that ENB has equal efficacy to TTNA, ENB was found to be dominant (less costly and more effective) when compared with TTNA, due to having a reduced risk and cost of adverse events. This conclusion was most sensitive to changes in the cost of intervention, estimates of effectiveness and adverse event rates. DISCUSSION: ENB is expected to be cost-effective when the likelihood of an accurate diagnosis is equal to (or better than) TTNA, which may occur in certain subgroups of patients in whom TTNA is unlikely to accurately diagnose malignancy or when an experienced practitioner achieves a high accuracy with ENB.

Is thyroid core needle biopsy a valid compliment to fine-needle aspiration?

Fine-needle aspiration (FNA) has long been considered the first and an important diagnostic tool in the evaluation of thyroid nodules. The advantages of FNA include simplicity, safety, cost-effectiveness, high diagnostic accuracy, and low complication rate. Nevertheless, limitations associated with FNA include a substantial rate of inconclusive results and indeterminate interpretations. Therefore, core needle biopsy (CNB) of the thyroid gland has been proposed as a complementary or even alternate diagnostic method to evaluate thyroid nodules. Although controversial, a growing number of researchers have reported CNB to be an effective and safe sampling method for thyroid nodules, especially for cases with inadequate or indeterminate FNA yields. Skeptics highlight local pain and bleeding risk. Supporters highlight the potential likelihood of overcoming FNA limitations by obtaining a larger amount of tissue and using architecture and cellular details to guide possible ancillary testing. This review evaluates the indications, advantages, and disadvantages of CNB as compared with FNA of the thyroid gland.

Cost-effectiveness of hydrogel plugs in CT-guided lung biopsies. / Estudio de coste-efectividad sobre la utilización de un tapón de hidrogel en las biopsias pulmonares guiadas por tomografía computarizada.

OBJECTIVE: Using a hydrogel plug decreases the number of cases of pneumothorax and reduces the need for pleural drainage tubes in CT-guided lung biopsies. We aimed to analyze the cost-effectiveness of using hydrogel plugs. MATERIAL AND METHODS: We analyzed 171 lung biopsies divided into three groups: Group 1 (n=22): fine-needle aspiration cytology (FNAC) without hydrogel plugs; Group 2 (n=89): FNAC with hydrogel plugs; and Group 3 (n=60): FNAC plus core-needle biopsy (CNB) with hydrogel plugs. We calculated the total costs (direct and indirect) in the three groups. We analyzed the percentage of correct diagnoses, the average and incremental rations, and the most cost-effective option. RESULTS: Total costs: Group 1 = 1,261.28 + 52.65 = € 1,313.93; Group 2 = 1,201.36 + 67.25 = € 1,268.61; Group 3 = 1,220.22 + 47.20 = € 1,267.42. Percentage of correct diagnoses: Group 1 = 77.3%, Group 2 = 85.4%, and Group 3 = 95% (p = 0.04). Average cost-effectiveness ratio: Group 1 = 16.99; Group 2 = 14.85; and Group 3 = 13.34. CONCLUSIONS: Group 3 was the best option, with the lowest average cost-effectiveness ratio; therefore, the most cost-effective approach is to do FNAC and CNB using a dehydrated hydrogel plug at the end of the procedure.

A highly aggressive invasive ductal carcinoma from a complex cystic breast mass and BI-RADS assessment: A case report.

RATIONALE: The term cystic breast lesions is a sonographic diagnosis, which can be categorized as simple, complicated or complex. The complex cysts are deemed as having a low risk of breast cancer. The highly aggressive invasive ductal carcinomas among complex cysts, in particular, are infrequent reported. PATIENT CONCERNS: A 56-year-old female with a breast complex cyst who, after fine-needle aspiration, complained about oozing with fluid as well as skin ulceration that did not heal. DIAGNOSES: An advanced HER-2-enriched invasive ductal carcinoma was diagnosed. INTERVENTIONS: The patient received neoadjuvant chemotherapy of anti-HER-2 target drug, palliative surgery and following postoperative chemotherapy. OUTCOMES: The patient was in good general condition at 6 months follow-up after surgery. LESSONS: Meticulous ultrasound evaluation of Breast Imaging Reporting and Data System (BI-RADS) category is crucial and indispensable when a complex cyst is found. The radiologist and clinician should be fully awake to its possibility of malignancy, especially fast-growing one in post-menopausal women. Excision biopsy may be preferred for diagnosis.

[Assessment of amylase and lipase levels following puncture biopsy and fine needle aspiration guided by endoscopic ultrasound in pancreatic lesions]. / Evaluación de los niveles de amilasa y lipasa posterior a la realización de biopsia por aspiración con aguja fina guiada por ultrasonido endoscópico en lesiones del páncreas.

BACKGROUND: Puncture biopsy and fine needle aspiration guided by endoscopic ultrasound has been used as an effective technique and is quickly becoming the procedure of choice for diagnosis and staging in patients suspected of having pancreatic cancer. This procedure has replaced retrograde cholangiopancreatography and brush cytology due to its higher sensitivity for diagnosis, and lower risk of complications. OBJECTIVE: To assess the levels of pancreatic enzymes amylase and lipase, after the puncture biopsy and fine needle aspiration guided by endoscopic ultrasound in pancreatic lesions and the frequency of post-puncture acute pancreatitis. MATERIAL AND METHODS: A longitudinal and descriptive study of consecutive cases was performed on outpatients submitted to puncture biopsy and fine needle aspiration guided by endoscopic ultrasound in pancreatic lesions. Levels of pancreatic enzymes such as amylase and lipase were measured before and after the pancreatic puncture. Finally we documented post-puncture pancreatitis cases. RESULTS: A total of 100 patients who had been diagnosed with solid and cystic lesions were included in the study. Significant elevation was found at twice the reference value for lipase in 5 cases (5%) and for amylase in 2 cases (2%), none had clinical symptoms of acute pancreatitis. Eight (8%) of patients presented with mild nonspecific pain with no enzyme elevation compatible with pancreatitis. CONCLUSION: Pancreatic biopsy needle aspiration guided by endoscopic ultrasound was associated with a low rate of elevated pancreatic enzymes and there were no cases of post-puncture pancreatitis.

Percutaneous CT guided lung biopsy in patients with pulmonary hypertension: Assessment of complications.

PURPOSE: To assess the complications of CT-guided percutaneous transthoracic needle aspiration and/or core biopsy (PTNAB) of lung nodules in patients with pulmonary arterial hypertension (PHTN). METHOD AND MATERIALS: We analyzed PTNAB of 74 lung lesions (mean size: 3.6 ± 2.1 cm) in 74 patients (M: F 38:36; age 68 ± 15 years) with documented PHTN on cardiac ultrasound. 39 patients with lung lesions (M: F 24:15; age 65 ± 14) who underwent PTNAB in the same period with right ventricle systolic pressure (RVSP) <35 mm Hg were selected as controls. Pulmonary arterial pressures were estimated on cardiac ultrasounds by using the tricuspid regurgitation jet method. Two thoracic radiologists reviewed the medical records and PTNAB images on a PACS station and documented nodule size, location, distance traversed in lung, technical success and complications. RESULTS: Fine needle aspirates were obtained in all and core biopsy in 23% (17/74) of the nodules. 61% (45/74) of the nodules were in the middle and 39% (29/74) were in the outer third of lung. PHTN was mild, moderate and severe in 84% (62/74), 13% (10/74) and 3% (2/74) of the patients. Biopsy was complicated by hemorrhage in 26% (19/74), moderate hemoptysis in 1.3% (1/74), pneumothorax in 17% (12/74), chest tube in 1.3% (1/74) and hemothorax in 1.3% (1/74) of the patients. The complications rate in control group was similar, hemorrhage in 33% (19/39) (p=0.6), moderate hemoptysis in 5% (2/39) (p=0.3), pneumothorax in 28% (11/39) (p=0.2), chest tube in (0/39) (p=0.3), and hemothorax in 3% (1/39) of the patients (p=0.7). CONCLUSION: Percutaneous needle biopsy of lung lesions in patients with mild to moderate PHTN can be performed without significant increase in complications.

The comparative effectiveness of fine-needle aspiration cytology sampling policies: a simulation study.

Sample adequacy is an important aspect of overall fine-needle aspiration cytology (FNAC) performance. FNAC effectiveness is augmented by an increasing number of needle passes, but increased needle passes are associated with higher costs and greater risk of adverse events. The objective of this study was to compare the impact of several different sampling policies on FNAC effectiveness and adverse event rates using discrete event simulation. We compared 8 different sampling policies in 12 different sampling environments. All sampling policies were effective when the per-pass accuracy is high (>80%). Rapid on-site evaluation (ROSE) improves FNAC effectiveness when the per-pass adequacy rate is low. ROSE is unlikely to be cost-effective in sampling environments in which the per-pass adequacy is high. Alternative ROSE assessors (eg, cytotechnologists) may be a cost-effective alternative to pathologists when the per-pass adequacy rate is moderate (60%-80%) or when the number of needle passes is limited.

Diagnostic endoscopic ultrasonography: assessment of safety and prevention of complications.

Endoscopic ultrasonography (EUS) has gained wide acceptance as an important, minimally invasive diagnostic tool in gastroenterology, pulmonology, visceral surgery and oncology. This review focuses on data regarding risks and complications of non-interventional diagnostic EUS and EUS-guided fine-needle biopsy (EUS-FNB). Measures to improve the safety of EUS und EUS-FNB will be discussed. Due to the specific mechanical properties of echoendoscopes in EUS, there is a low but noteworthy risk of perforation. To minimize this risk, endoscopists should be familiar with the specific features of their equipment and their patients' specific anatomical situations (e.g., tumor stenosis, diverticula). Most diagnostic EUS complications occur during EUS-FNB. Pain, acute pancreatitis, infection and bleeding are the primary adverse effects, occurring in 1% to 2% of patients. Only a few cases of needle tract seeding and peritoneal dissemination have been reported. The mortality associated with EUS and EUS-FNB is 0.02%. The risks associated with EUS-FNB are affected by endoscopist experience and target lesion. EUS-FNB of cystic lesions is associated with an increased risk of infection and hemorrhage. Peri-interventional antibiotics are recommended to prevent cyst infection. Adequate education and training, as well consideration of contraindications, are essential to minimize the risks of EUS and EUS-FNB. Restricting EUS-FNB only to patients in whom the cytopathological results may be expected to change the course of management is the best way of reducing the number of complications.

Impact of fine needle aspiration (FNA) and of the number of punctures on the feline testis: clinical, gross anatomy and histological assessment.

The safety of testicular fine needle aspiration (FNA) has been proven in dogs but has not been fully established in men, while studies in rats have given contradictory results. Furthermore, the extent of damage inflicted by multiple punctures is unknown. The aim of this study was to determine the impact of FNA and of the number of punctures on the feline testis with clinical, gross anatomy and histological examinations. Twenty-seven sexually mature healthy laboratory Domestic Shorthair cats were randomly assigned to two groups: 5 cats in which no FNA was performed (control group), and 22 cats which had their left and right testis punctured with a 26 ga needle towards 3 and 8 directions, respectively (experimental group). Two cats at a time were orchiectomized 5 or 30 min, 1, 2, 4, 7 or 14 days or 1, 2, 3 or 4 mo post-aspiration. The cats of the control group were also orchiectomized. During the first week post-aspiration clinical examination revealed vaginal cavity hematoma (8/44 testes), while the histological findings were focal hemorrhagic areas (20/24 testes), erythrocytes inside the seminiferous tubules' lumen (9/24 testes), and germinal cell degeneration in <1.94% of the seminiferous tubules (15/24 testes). After the first week the histological findings were germinal cell degeneration in <2.14% of the seminiferous tubules (19/20 testes) and enlargement of the lumen of <5.16% of the seminiferous tubules (7/20 testes). The germinal epithelium and interstitium had an overall normal appearance. No significant differences were observed between the left and right testis. The results of the study indicate that testicular FNA should be considered a safe procedure in the cat when up to 8 punctures are performed.

First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos).

BACKGROUND: Challenges in EUS-guided FNA (EUS-FNA) include sampling error, nondiagnostic cytology, and limited on-site cytological evaluation. A prototype needle-based confocal laser endomicroscopy (nCLE) probe is a submillimeter probe that provides real-time imaging at the microscopic level through the FNA needle. OBJECTIVE: To evaluate the feasibility of nCLE during EUS-FNA of pancreatic lesions. DESIGN: Feasibility study. SETTING: Multicenter, tertiary care. PATIENTS: Eighteen patients presenting for EUS-FNA. INTERVENTIONS: Patients were injected with 2.5 mL of 10% fluorescein. The lesion was interrogated with the nCLE probe positioned at the tip of a 19-gauge FNA needle. MAIN OUTCOME MEASUREMENTS: Device integrity, technical ease, safety, and image acquisition. RESULTS: Cases included 16 cysts and 2 masses. There were no device malfunctions. Technical challenges were encountered in 6 of 18 attempts to image and reflected challenges with a postloading technique, the longer ferule tip, and a transduodenal approach. Technical feasibility to perform imaging with nCLE during a pancreatic EUS-FNA procedure was achieved in 17 of 18 cases. Ten cases had good to very good image quality. Two serious adverse events occurred; both were pancreatitis requiring hospitalization. LIMITATIONS: Limited sample size, small number of patients with confirmed pathological diagnosis, lack of coregistered pathology and images. CONCLUSIONS: nCLE in the pancreas is technically feasible via a 19-gauge needle under endosonographic guidance. Future studies will address identification of structures, diagnostic accuracy, and complication profiles. The rate of pancreatitis needs to be further clarified and mitigated.

Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review.

BACKGROUND: EUS-guided FNA (EUS-FNA) permits both morphologic and cytologic analysis of lesions within or adjacent to the GI tract. Although previous studies have evaluated the accuracy of EUS-FNA, little is known about the complications of EUS-FNA. Moreover, the frequency and severity of complications may vary from center to center and may be related to differences in individual experience. OBJECTIVE: To systematically review the morbidity and mortality associated with EUS-FNA. DESIGN: MEDLINE and EMBASE were searched to identify relevant English-language articles. MAIN OUTCOME MEASUREMENTS: EUS-FNA-specific morbidity and mortality rates. RESULTS: We identified 51 articles with a total of 10,941 patients who met our inclusion and exclusion criteria; the overall rate of EUS-FNA-specific morbidity was 0.98% (107/10,941). In the small proportion of patients with complications of any kind, the rates of pancreatitis (36/8246; 0.44%) and postprocedure pain (37/10,941; 0.34%) were 33.64% (36/107) and 34.58% (37/107), respectively. The mortality rate attributable to EUS-FNA-specific morbidity was 0.02% (2/10,941). Subgroup analysis showed that the morbidity rate was 2.44% in prospective studies compared with 0.35% in retrospective studies for pancreatic mass lesions (P=.000), whereas it was 2.33% versus 5.07% for pancreatic cysts (P=.036). LIMITATIONS: Few articles reported well-designed, prospective studies and few focused on overall complications after EUS-FNA. CONCLUSIONS: EUS-FNA-related morbidity and mortality rates are relatively low, and most associated events are mild to moderate in severity.

Impact of fine or large needle aspiration on the dog's testis: in vitro ultrasonographic, bacteriological, gross anatomy and histological assessment.

Despite its extensive use for evaluation of spermatogenesis and assisted reproduction, the safety and consequences of fine (FNA) and large needle aspiration (LNA) to the testicular parenchyma and its normal function have not been established. This study was performed in order to accurately assess, by serial in vitro ultrasonographic, bacteriologic, gross anatomic and histological examinations, the type and extent of the effect of FNA or LNA on the dog's testis. Twenty three sexually mature, 1 to 2 years old, healthy laboratory Beagles were randomly assigned to 2 groups: (1) 5 dogs without testicular aspiration (control group) and (2) 18 dogs in which one of their testes was aspirated using a 23 G butterfly needle and the other using a 19 G butterfly needle (experimental group). Two dogs at a time were castrated 10 minutes, 60 minutes, 2, 14, 29, 63, 76, 90 or 180 days post-aspiration. The control group was also castrated 2, 29, 63, 90 or 180 days after the beginning of the experiment. Following castration, in vitro ultrasonographic, gross anatomic, cytological examinations of epididymal sperm, bacteriologic and histological examinations of the testes were performed. Following testicular FNA and LNA bacteriologic, gross anatomic, histologic, epididymal sperm findings and the in vitro ultrasonographic appearance of the testis were normal, except of intratesticular haemorrhage, detected the first days post-aspiration, and degeneration of less than 1.5% of the seminiferous tubules. Within the parameters of this experiment, testicular FNA and LNA have no ill effect on the canine testis and therefore, both FNA and LNA should be considered safe.

Prospective cytological assessment of gastrointestinal luminal fluid acquired during EUS: a potential source of false-positive FNA and needle tract seeding.

OBJECTIVES: Endoscopic ultrasound (EUS) fine needle aspiration (FNA) can result in false-positive cytology and can also cause needle tract seeding. Our goal was to evaluate a potential cause, namely, the presence of malignant cells within gastrointestinal (GI) luminal fluid, either as a result of tumor sloughing from luminal cancers or secondary to FNA of extraluminal sites. METHODS: During EUS, luminal fluid that is usually aspirated through the echoendoscope suction channel and discarded was instead submitted for cytological analysis among patients with cancer and benign disease. Pre- and post-FNA luminal fluid samples were collected to discern the role of FNA in inducing a positive cytology. When not performing FNA, one sample was collected for the entire examination. The final diagnosis was based on strict clinicopathological criteria and >or=2-year follow-up. This study was conducted in a tertiary referral center. RESULTS: We assessed the prevalence of luminal fluid-positive cytology among patients with luminal (e.g., esophageal), extraluminal (e.g., pancreatic), and benign disease. Among the 140 patients prospectively enrolled with sufficient sampling and follow-up, an examination of luminal fluid cytology showed positive results for malignancy in luminal and extraluminal cancer patients, 48 and 10%, respectively. This included 8 out of 23 esophageal, 4 of 5 gastric, and 9 of 15 rectal cancers. The positive luminal fluid cytology rate with luminal cancers was not affected by performing FNA. Post-FNA luminal fluid cytology was positive in 3 out of 26 with pancreatic cancers. Cytological examination of luminal fluid aspirates did not demonstrate malignant cells in any patient with nonmalignant disease. CONCLUSIONS: Malignant cells are commonly present in the GI luminal fluid of patients with luminal cancers and can also be found in patients with pancreatic cancer after EUS FNA. Further study is needed to determine the impact of these findings on cytological interpretation, staging, risk of needle tract seeding, and patient care and outcomes.

Prospective assessment of diagnostic utility and complications of endoscopic ultrasound-guided fine needle aspiration. Results from a newly developed academic endoscopic ultrasound program.

BACKGROUND: It is currently unknown whether a newly developed endoscopic ultrasound (EUS) program can produce results similar to those of experienced EUS centers. We therefore prospectively evaluated the diagnostic accuracy and major complications of EUS-guided fine needle aspiration (EUS-FNA) in a newly developed EUS program. METHODS: All procedures were performed by a single endosonographer in the presence of a cytopathologist. Reference standard for classification of final disease included: surgical resection, death from disease progression and repeat radiologic and/or clinical follow-up. Major complications were defined as oversedation, and those that resulted in a physician or emergency department visits, hospitalization, or death. RESULTS: 540 patients (median age 63 years, 77% white) underwent EUS-FNAs of 656 lesions: lymph nodes (LNs, n = 248), solid pancreatic masses (SPMs, n = 229), cystic pancreatic masses (CPM, n = 57), mural lesions (n = 41), bile duct/gallbladder (n = 28), liver (n = 17), mediastinum/lung (n = 17), adrenal (n = 15), spleen (n = 3) and kidney (n = 1). SPMs and bile duct/gallbladder lesions were more likely to have suspicious/atypical cytology when compared to other lesions (8.7 vs. 4.6%; p = 0.04) and required more passes to achieve a tissue diagnosis (p < 0.001). The overall sensitivity, specificity, PPV, NPV and accuracy of EUS-FNA was 91.7, 97.1, 98.1, 87.7 and 93.8%, respectively. Six patients (1.1%) (95% CI 0.4-2.4) experienced a major complication. One patient died shortly after the procedure due to preexisting pulmonary embolus (0.18%). CONCLUSION: EUS-FNA is highly accurate and safe in sampling a variety of peri-intestinal organs and lymph nodes. With adequate third-tier training, a newly developed program can produce results similar to those from expert EUS centers.