Gland and Hormone Related Diseases

All Conditions

Neoplasms

Behaviors and Mental Disorders

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Quality of Life

patients will then be randomized routine FNAC strategy

patients will be randomized to watchful observation strategy (no FNAC)

Fine Needle Aspiration Cytology

Ideally randomized controlled trials should be carried out to compare the cost-effectiveness between FNAC and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time.

The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the Chinese population in Hong Kong.

Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules

A Prospective Randomized Study on Health-related Quality of Life of Patients With Incidental Small (<2cm) Asymptomatic Thyroid Nodules and Cost-effectiveness Analysis in Managing Small Incidental Thyroid Nodules

Health-related Quality of Life (HRQoL) preference value measured by The Chinese (HK) SF-6D Health Survey will be calculated by the Hong Kong population specific algorithm. It ranges from 0 (dead) to 1 (perfect health)

The effectiveness of managing small incidental thyroid nodules is quantified by quality-adjusted life years (QALYs), which will be calculated as the product of average duration of each stage (including no illness) and the SF-6D preference value for that particular health state.

The direct health care costs of different strategies in managing small incidental thyroid nodules will be estimated using the costs published by the Government Gazette and previous literatures.

HRQOL measured by the Chinese (Hong Kong) Short Form-12 (SF-12) Health Survey version 2 and FACT-G will be evaluated to identify these major problem of life.

Health service utilizations of patients with thyroid neoplasm will be surveyed.

Treatment effect on the HRQOL of patients with thyroid carcinoma will be explored.

The University of Hong Kong

Associate Professor

Comparison between FNAC and post operative specimen after thyroid surgery

Amr M Makky, specialist surgical onclogy

Abdullah Atyah Ali, Ass.Lecture General Surgery

Mohamed Ahmed Orabi, specialist surgical onclogy

Mina Romany Tawfeek

Mahmoud Ahmed Dosoky, specialist pathology

Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant \[1\].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).

it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.\[2,3\] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.\[4\] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid \[5\].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules \[2,3\]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm \[2\]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious \[3\].

Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience

Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience

type of thyroid malignancy not observed by FNAC

false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion

Qena Oncology Center

specialist of surgical oncology at Qena Oncology Center

Symptoms and General Pathology

Mouth and Tooth Diseases

Rare Diseases

Body Weight

Parotid Neoplasms

Salivary Gland Neoplasms

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Parotid Diseases

Salivary Gland Diseases

Oral Cancer

Preoperative Assessment of Parotid Gland Neoplasms with:

* Clinical Evaluation;
* Fine Needle Aspiration Cytology;
* Multiparametric Magnetic Resonance Imaging.

Postoperative Collection of Final Histopathological Diagnosis

Multiparametric MRI evaluation includes Conventional MRI, Diffusion-Weighted MRI and Dynamic Contrast-Enhanced MRI

Multiparametric Magnetic Resonance Imaging

Ultrasound-Guided Fine Needle Aspiration Cytology

Patient's history and physical examination, reporting signs and symptoms suggestive of malignancy (pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, weight loss)

Clinical Evaluation

Final Diagnosis of the Disease from the Pathology Report after Surgical Resection of the Lesion

Final Histopathological Diagnosis

Davide Di Santo, MD

Parotid gland tumors are mostly treated surgically, but the extent of parotidectomy is decided upon preoperative work-up information. Preoperative management generally includes clinical evaluation, collection of a pathological sample, most often through fine-needle aspiration cytology (FNAC), and imaging. FNAC, despite its high sensitivity and specificity, has the drawback of an approximately 20 per cent rate of nondiagnostic or indeterminate result. Magnetic Resonance Imaging (MRI) provides the best morphological description of the lesion, which is helpful to the surgeon for the planning of the intervention. Recently, advanced functional techniques have been introduced, in association to the conventional morphologic ones: diffusion-weighted imaging (DWI) and dynamic contrast-enhanced imaging (DCEI) demonstrated the ability to provide information about the possible histological origin of parotid lesions. Multiparametric MRI (mp-MRI) comes from the combination of anatomical and functional sequences.

The Authors postulate that mp-MRI evaluation may be able to provide information not only about the extension of the lesion, but also about histology, with a high accuracy, at least comparable to ultrasound-guided FNAC.

In the present study, the Authors aim to define the value of FNAC and mp-MRI in the preoperative management of parotid gland tumors, comparing their success intended as the capability of the exam to be both diagnostic and accurate in formulating the correct histological suspect of malignancy.

Participants are patients affected by parotid gland neoplasms, candidates for surgical resection. The lesion will preoperatively be assessed with both clinical evaluation, ultrasound-guided FNAC and mp-MRI in our Institution. Mp-MRI includes conventional sequences, DWI and DCEI; its interpretation will allow the definition of the suspect histology. FNAC and mp-MRI suspects will be compared to the final histopathological report after surgical removal of the neoplasm.

The study considers a total of 100 patients, of whom 50 are analyzed retrospectively (being already operated after obtaining both FNAC and mp-MRI preoperatively) and the remaining 50 to be enrolled prospectively.

Participants affected by parotid gland neoplasms are evaluated by an ear, nose and throat surgeon in our hospital, who defines the indication to surgical removal.

Preoperative management includes:

* Clinical Evaluation: participant's history and physical examination are collected. Participants are asked for the presence of pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, B symptoms.
* FNAC: it is always performed under US guidance in our Department of Radiology, and subsequently analyzed by a cytopathologist in our Department of Pathology. The same sampling technique is always employed. After skin disinfection, a 23-gauge needle attached to a syringe is inserted into the lesion and moved inside it to obtain enough cytological material. The material is subsequently expelled onto a glass slide, and the smear is prepared between two glass slides and fixed. The procedure is repeated two to three times to reduce the probability of nondiagnostic results.
* mp-MRI: MRI scans are conducted using a 1.5-T imager (Philips Health-care, DA Best, The Netherlands) with a head and neck array coil. The MRI study protocol consists of localizer sequences in transversal, sagittal and coronal planes followed by two axial T2 weighted images: a T2 Turbo Spin-Echo (repetition time -TR-: 4465, echo time -TE-: 80, section thickness: 3mm, intersection gap: 0.3mm) centered on parotid glands and a T2 MV sequence for lymph nodes identification (TR: 3000, TE: 83, section thickness: 4mm, intersection gap: 0.4mm). Then axial T1 weighted images are obtained (TR: 571, TE: 16, section thickness: 3 mm, intersection gap: 0.3mm). Coronal T1, T2 and STIR images are subsequently obtained. Thereafter, DWI is performed by using a multisection spin-echo singleshot echoplanar sequence in the transverse plane (TR: 2800, TE: 160, 20 - 25cm field of view, 92 x 90 matrix, 3mm section thickness). Sensitizing diffusion gradients are applied sequentially in the x, y, and z directions with b values of 0, 500, and 1000 sec/mm2. ADC maps are generated. After detecting the mass in the morphological images, The Radiologist identifies corresponding slice position for a T1 weighted FLASH sequence (TR: 30, TE: 4.6) in the transversal plane, used for DCEI. Each patient receives intravenous contrast injection (weight-adapted dosage, 0.1ml Gadolinium per Kilogram body weight) with a flow rate of 2ml/second using a power injector, followed by a 20ml saline flush. The contrast agent application and the T1-weighted FLASH sequence are started simultaneously. MR images are sequentially obtained at 5sec intervals for 360sec. After DCEI, postcontrast T1 weighted spin echo images are obtained, with the parameters similar to those of the pre-contrast imaging. A region of interest (ROI) for signal intensity measurement is drawn manually avoiding the vessels and necrotic or cystic portions of the tumors. Thereafter, the Radiologist plots the average signal intensity within the ROI against time, and a Time Intensity Curve (TIC) is constructed, using a dedicated software (Philips Intellispace Portal). The ROI can be identified with an adequate accuracy only for tumors with a minimum diameter of 1cm; therefore for smaller lesions a mp-MRI analysis is not possible. TICs are constructed as follows: Time to peak (Tpeak) is manually positioned by the Radiologist in the first value of the curve in which the signal intensity (SI) reached the 90% of the difference between the maximum (SImax) and the starting (SIpre) signals: Tpeak \> 0.9 (SImax - SIpre) + SIpre. Washout Ratio (WR) is calculated at 300sec (SIend) and expressed as a percentage, using the following equation: WR = \[(SImax - SIend) / (SImax - SIpre)\] x 100 (%). TICs are defined as follows: Type A: Tpeak \> 120sec (gradual enhancement, ascending plateau); Type B: Tpeak ≤ 120sec and WR ≥ 30% (early enhancement, early washout); Type C: Tpeak ≤ 120sec and WR \< 30% (early enhancement, late washout); Type D: flat curve (vacillation of the curve around the low signal level may be observed due to imaging artifacts).

Interpretation of preoperative management findings aims to label each case as "benign" or "malignant", and is performed as follows:

* Clinical Evaluation: malignancy is suspected if any of pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, B symptoms is present.
* FNAC results were classified as: "benign" if a specific histologically benign diagnosis was made, if the report stated "no evidence of malignancy", or if only benign diagnoses were listed in the differential; "malignant" if a specific histologically malignant diagnosis was made, if malignant cells were identified, if the report stated "suspicious for malignancy" or "suspicious for lymphoproliferative disorder". The decision to consider as malignant also reports stating "suspicious for" comes from the observation that surgeons would manage these lesions as malignant anyway; "indeterminate" if, despite the presence of a cytologically adequate sample, the pathologist was not able to define the benign or malignant nature of the lesion; "nondiagnostic" if the pathological sample was insufficient or did not contain enough meaningful material.
* Conventional MRI results are classified as "malignant" if: presence of infiltration of surrounding non-glandular structures (including the facial nerve) is identified; presence of suspect metastatic lymph nodes is identified; the tumor is characterized by low signal on T2-weighted images and displays ill-defined borders. All other cases were classified as "benign".
* Multiparametric MRI results are recorded, and interpreted according to a stepwise approach. The first step of mp-MRI interpretation is the evaluation of conventional MRI findings. If the tumor presented features undoubtedly indicating a malignant origin (infiltration of contiguous non-glandular structures - including the facial nerve - or evidence of lymph node metastases), the lesion is immediately labeled as "malignant" at mp-MRI. The third category used to define malignant nature at conventional MRI evaluation, such as low signal on T2-weighted images and ill-defined borders is not considered as undoubtedly indicating malignancy, and further steps of mp-MRI evaluation are performed. After conventional MRI evaluation, advanced MRI techniques are used. The second step includes DWI with ADC maps generation and measurement. Depending on the ADC value, three main categories are identified: 1. tumors with extremely low ADC value (\< 0.6 x 10\^-3 mm2/sec); 2. tumors with low or intermediate ADC value (≥ 0.6 x 10\^-3 mm2/sec and ≤ 1.4 x 10\^-3 mm2/sec);
* tumors with high ADC value (\> 1.4 x 10\^-3 mm2/sec). The third step is the construction of a TIC using DCEI. Findings obtained with both DWI and DCEI are combined and interpreted as follows: A. high ADC value (\> 1.4 x 10\^-3 mm2/sec) and TIC type A, B (not plausible) or C are most often suggestive of a Pleomorphic Adenoma (PA), but also of myoepithelioma. Due to the rarity of myoepithelioma and to the fact that its surgical treatment is essentially the same of PA, this eventuality is not considered. TIC type B is not considered a plausible possibility, as this finding is very rarely reported in PAs. In such cases, a hemorrhagic complication after a recently performed FNAC in a Warthin Tumor (WT) should be considered. Tumors in this category are labeled as "benign", with suspected histology of PA; B. high ADC value (\> 1.4 x 10\^-3 mm2/sec) and TIC type D can be referred to cystic lesions. Cysts are characterized by very high ADC values, being composed of fluid or mucinous content. Tumors in this category are labeled as "benign", with suspected histology of cystic lesion; C. low or intermediate ADC value (≥ 0.6 x 10\^-3 mm2/sec and ≤ 1.4 x 10\^-3 mm2/sec) and TIC type A or C are typical of malignant epithelial tumors, but also of some atypical adenomas (cellular adenomas, basal cell adenomas). In an attempt to reduce the number of false negative results, tumors in this category are labeled as "malignant". No specific tumor histology can be suspected, due to the large overlap of findings and the high number of parotid gland malignant histotypes; D. low or intermediate ADC value (≥ 0.6 x 10\^-3 mm2/sec and ≤ 1.4 x 10\^-3 mm2/sec) and TIC type B are typical of WTs. Tumors in this category are labeled as "benign", with suspected histology of WT; low or intermediate ADC value (≥ 0.6 x 10\^-3 mm2/sec and ≤ 1.4 x 10-3\^mm2/sec) and TIC type D are not plausible, as TIC type D is typical of cysts, which are characterized by very high ADC values. In such cases, one should consider the possibility of repositioning the ROI, as this finding may be related to positioning of the ROI in a necrotic or cystic portion (therefore not informative) of a parotid tumors; E. extremely low ADC value (\< 0.6 x 10\^-3 mm2/sec) and TIC type A (not plausible), B or C are suggestive of parotid gland lymphomas. Tumors in this category are labeled as "malignant", with suspected histology of lymphoma; F. extremely low ADC value (\< 0.6 x 10\^-3 mm2/sec) and TIC type D are suggestive of lipomas. Lipomas display typical very low ADC values. Tumors in this category are labeled as "benign", with suspected histology of lipoma; G. mp-MRI IS considered "indeterminate" if the exam is unable to reliably measure ADC or construct a TIC, due to a very recently performed FNAC (less than two weeks) with reported complications (clinical evidence of infection or conventional MRI evidence of intralesional hemorrhage), or intense movement artifacts.

Study power analysis:

The number of participants to be treated is decided taking into account the paired design of the study, to detect any difference in the percentage of success (intended as the capability of the diagnostic test to be diagnostic and to correctly identify malignant tumors) between the two tests (FNAC and mp-MRI), assuming a percentage of participants for whom mp-MRI has success while FNAC does not of 20%, a percentage of participants for whom FNAC has success while mp-MRI does not of 5%, a power of 80% and an alfa error of 5%. These percentage strictly depend on the expected rate of non success due to indeterminate or nondiagnostic results of the tests. Therefore, we defined to be 100 participants the number to be treated.

Statistical analysis:

Number of indeterminate and nondiagnostic results, sensitivity, specificity, positive predictive value, negative predictive value and accuracy of Clinical Evaluation, FNAC, conventional MRI and mp-MRI will be reported. The comparison between success of respectively FNAC and mp-MRI will be investigated with the McNemar test. SPSS software (IBM Corporate, US) will be used. P will be considered to be significant if \< 0.05.

Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms

Accuracy of Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology in the Preoperative Work-Up of Parotid Gland Neoplasms

No consent from the participants to share data

Success is intended as the capability of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) to be diagnostic (i.e. to make a diagnosis of benignity or malignancy) AND to correctly identify malignant tumors, compared to the final histopathological report

Diagnostic accuracy of the test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) is defined as the number of malignant lesions with "malignant" results in addition to benign lesions with "benign" results as a percentage of the total number of lesions

Diagnostic accuracy of the test (Multiparametric MRI and Fine Needle Aspiration Cytology) is intended as the capability to preoperatively identify the histopathology of the tumor (pleomorphic adenoma, warthin tumor, carcinoma, lymphoma)

Davide Di Santo

Principal Investigator

EUS 22 g needle is the most common needle used in clinical practice. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

25 gauge needle is usually used less frequently but nowadays is increasingly used and is as well a valid option. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)

Anand V Sahai, MD

This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in consecutive patients.

Summary

Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies comparing them regarding efficacy and feasibility are lacking.

Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of the conventional 22 G compared with the 25 G needle.

Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant coagulopathy (APT \< 50% or platelets \< 50000/mm3), use of warfarin or other anticoagulants, use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent and pregnancy or suspected pregnancy will be excluded.

Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. The diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value. An expected rate of 85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.

1. Objectives

PRIMARY To compare diagnostic yield of stylet-free, solid lesion EUS-FNA using the 22 G FNA vs the 25 G FNA needle, in consecutive patients referred to EUS-FNA.

SECONDARY

To investigate:

1. specimen adequacy,
2. number of FNA passes,
3. ease of puncture,
4. failure of the FNA needle and
5. complications

3. Methods

3.1. Design: prospective randomized trial.

3.2. Inclusion: Consecutive patients referred for EUS-FNA of a solid lesion will be considered for inclusion.

3.3. Exclusion: Age \< 18 years, patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis, significant coagulopathy (INR \> 1.5, platelets \< 50000/mm3, use of low molecular weight heparin, use of clopidogrel within 7 days of EUS), cystic lesions, or inability or refusal to sign the informed consent.

3.4. Endoscopic procedures: Informed consent will be obtained before each procedure by one of the researchers. Patients will not receive economic compensation or reimbursement of their expenses for coming to the exploration, since it is a procedure previously indicated. Then, potential candidates will be randomized to 22 G or 25 G FNA using a computer generated random sequence. There will be block randomization for a) pancreatic masses, 2) lymph nodes, or 3) all other lesions.

All examinations will be performed by two experienced endosonographers with a lineal echoendoscope (AS and SP). EUS procedures will be carried out with the patient, in left lateral position under conscious sedation using midazolam (2.5-5 mg) plus meperidine (50-100 mg) and droperidol (2.5-5 mg). Before performing the EUS-FNA biopsy, a complete examination of the pancreas, liver as well as other vicinity organs will be performed.

EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed. Ease of puncture will be scored qualitatively as poor (scored 1), good (scored 2) or excellent (scored 3).\[14\] FNA failure will be also reported. All procedures will be digitally videotaped. The examinations will be reviewed by a endosonographer blinded to the type of needle used and visibility of the needle will be scored (score 1 "poor", score 2 "good", score 3 "excellent").\[14\] After the procedure, patients will be monitored in the recovery room at least 60 minutes before discharge. Immediate complications will be assessed and recorded by nurses and/or physicians during and after the procedure while the patient was recovering from sedation.

3.5. Cytological analysis: All passes will be read by one experienced cytopathologist on-site utilizing microscopic evaluation of air-dried slides stained with Diff-Quik (International Reagents Co., Ltd., Kobe, Japan). The cytopathologist will be blinded to the type of needle used. The final cytological diagnosis was made using a standard Papanicolaou stain. For each lesion, the cytologist assessed sample adequacy: cellularity (score 1 "poor", score 2 "good", score 3 "excellent"),\[14\] and bloodiness (score 1 "minimal", score 2 "moderate", score 3 "significant")\[21\] and the presence or absence of malignancy ("positive"/"negative"/"suspicious"/ inconclusive).

3.6. Follow up Lesions will be considered malignant in the following cases: positive cytological diagnosis, positive histological diagnosis and clinical or radiological progression in the next 6 months. In case of negative results in the cytological diagnosis absence of clinical worsening and radiologic progression at least in the following 6 months after FNA will be required.

3.7. Data collection Clinical data will be prospectively collected and saved in a database including: demographic information (age and gender), size and location of the target lesion (pancreas, lymph node, liver, adrenal gland, others) and technical and procedure variables: FNA path (esophagus, stomach, duodenum), number of needle passes, needle visibility, ease to puncture, needle failure, cellularity, bloodiness, cytological diagnosis, final diagnosis, immediate complications.

4. Statistical analysis Results for continuous variables will be expressed as means and standard deviations. Categorical variables will be expressed as frequencies and percentages. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. Data were analyzed with the Statistical Package for Social Sciences v. 15.0 (SPSS Inc., Chicago, IL, USA). The diagnostic yield of 15 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value.

Sample size An expected rate of diagnostic yield from EUS guided FNA by using 22G needle of 85% will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules	NCT02398721	Thyroid Nodules	Fine Needle Asp...	18 Years -	The University of Hong Kong
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience	NCT05521594	Fine Needle Asp... Thyroid Disease...	Fine Needle Asp...	15 Years - 80 Years	Qena Oncology Center
Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms	NCT03849482	Parotid Neoplas... Parotid Cancer	Multiparametric... Fine Needle Asp... Clinical Evalua... Final Histopath...	18 Years -	IRCCS San Raffaele
Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles	NCT01543282	Solid Neoplasms	Endosonography ...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)

Spots Global Cancer Trial Database for fine needle aspiration cytology