Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial
Phase: NA
Conditions: Endoscopic Ultrasound, Fine-needle Aspiration
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

1 
Version 2, 18/03/2021 
 
STUDY TITLE: 
 
 
 
WET-SUCTION VERSUS SLOW-PULL TECHNIQUE FOR ENDOSCOPIC ULTRA-
SOUND-GUIDED FINE-NEEDLE BIOPSY OF SOLID LESIONS: A MULTICENTRIC 
RANDOMIZED CONTROLLED TRIAL 
 
 
SHORT TITLE: WET SUCTION VERSUS SLOW-PULL FOR EUS-FNB OF SOLID LESIONS 
CODICE: WEST-FNB 
 
 
 
PROMOTER: University of Verona Hospital Trust – Gastroenterology and Digestive Endoscopy 
Unit 
 
PRINCIPAL INVEESTIGATOR:  
Stefano Francesco Crinò, MD 
Gastroenterology and Digestive Endoscopy Unit,  
University of Verona Hospital Trust, 
Verona, Italy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
Index 
1. 
INTRODUCTION .......................................................................................................... 4 
2. 
STUDY AIMS AND ENDPOINTS .................................................................................. 5 
3. 
PLAN OF INVESTIGATION ......................................................................................... 8 
Design of the study ............................................................................................................ 8 
EUS-FNB procedures and samples processing .............................................................. 8 
Drop out .............................................................................................................................. 9 
Randomization and blinding ............................................................................................. 9 
Follow-up ............................................................................................................................ 9 
Flow-chart of the study ................................................................................................... 10 
Collected data and data management .......................................................................... 11 
Enrollment and duration of study .................................................................................. 11 
4. 
SAMPLE SIZE AND STATISTICAL ANALYSES ......................................................... 12 
Sample size calculation ................................................................................................... 12 
Statistical analyses .......................................................................................................... 12 
5. 
ETHICAL CONSIDERATIONS ................................................................................... 12 
Regulation statement ...................................................................................................... 12 
Treatment and storage of biological samples .............................................................. 13 
Recruitment and consent ............................................................................................... 13 
Data management and procedures to guarantee the confidentiality of the data .... 14 
6. 
AUTHORSHIP RULES ................................................................................................ 16 
7. 
REFERENCES ............................................................................................................ 17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
EUS: endoscopic ultrasonography 
TA: tissue acquiring 
FNA: fine needle aspiration 
FNB: fine needle biopsy 
SPT: slow-pull technique 
DST: dry suction technique 
WST: wet suction technique 
 
 
 
 
 
 
 
 

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1. INTRODUCTION 
 
 
 
Endoscopic ultrasound (EUS) with fine-needle aspiration (EUS-FNA) has become an essen-
tial tool for the diagnosis of solid pancreatic lesions (SPLs) and extrapancreatic lesions with 85% 
sensitivity and 98% specificity [1]. 
 
Several factors have been studied to optimize outcomes of EUS-FNA [1], such as the use of 
rapid on-site evaluation (ROSE) for immediate cytopathologic assessment [2], needles calibres and 
types [3], number of needle passes [4], and sampling techniques [5]. Currently, sampling techniques 
include standard suction (SS), slow-pull (SP) and wet-suction (WS).  
 
The SS was the first technique used during EUS-FNA. It is performed applying a negative 
pressure suction at the proximal end of the needle after the stylet is removed with an air-filled pre-
vacuum 10/20 ml syringe [6].  
 
Differently, in the SP technique, after advancing the needle inside the lesion, the stylet is 
slowly removed, thus applying a capillary suction, while the operator performs some needle back and 
forth movements inside the lesion [7].  
 
The WS relies on pre-flushing the needle with saline to replace the column of air with fluid, 
followed by aspiration at the proximal end of the needle, using a pre-vacuum 10/20 ml syringe [8,9] 
 
A recent meta-analysis including seven randomized controlled trials compared the outcomes 
of SS versus SP for sampling of SPLs with EUS-FNA has been published [10]. The SP technique 
demonstrated similar adequacy and accuracy when compared to SS, with a non-significant trend in 
favour of SP (OR = 0.82; 95 % CI 0.36–1.85; P = 0.63) and moderate heterogeneity that was not 
explained by the sensitivity analyses. However, a significant improvement in bloodiness of the sam-
ples using the SP has been demonstrated [10]. 
 
In a single-blinded randomized trial on 117 patients comparing the WS with the SS for FNA, 
the WS yielded in significantly higher cellularity (1.82± 0.76 vs. 1.45±0.768, P<0.0003) and better 
specimen adequacy (85.5% vs. 75.2%, P<0.035) [9]. Recently, Wang et al. compared diagnostic ac-
curacy in SS and WS for FNA of solid lesions (intrabdominal and mediastinal) in a multicentre ran-
domized controlled trial. Among the 269 patients with pancreatic (n=161) and non-pancreatic 
(n=108) lesions analysed, the WS had a significantly better histological diagnostic accuracy (84.9% 
[95% confidence interval (CI) 79.9%–89.0%] vs. 73.2% [95%CI 67.1%–78.7%]; P= 0.001), higher 
specimen adequacy (94.8% vs. 78.8%; P< 0.001), and less blood contamination (P<0.001) than the 
SS technique [11]. 
 
All the aforementioned studies investigated the performance of the different sampling tech-
niques in the setting of EUS-FNA. In the last decade, however, new EUS needles for the acquisition 

5 
of histological specimens have been developed with the purpose to overcome the limitations of cy-
tology and obviate the need for ROSE.   
 
In particular, end-cutting forward-acquiring needles (SharkCore™, Covidien/Medtronic, Bos-
ton, Massachusetts, and Acquire™, Boston Scientific, Marlborough, Massachusetts) have shown ex-
cellent histological yield [12,13], and several randomized trials have demonstrated their superiority 
compared with standard [14,15] and side-fenestrated needles [16], while they performed equally 
when compared each other in two randomized trials and one metanalysis [17-19]. Because of the high 
diagnostic accuracy of fine-needle biopsy (FNB) needles, current practice in moving from EUS-FNA 
to EUS-FNB [20].  
 
The histological yield of newest generation histological needles is changing the role of EUS-
FNB from diagnostic to prognostic and theranostic tool to drive precision medicine [21]. Develop-
ment of next-generation sequencing (NGS) technologies has increased the speed and reduced the cost 
of sequencing the nucleic acids of cancer cells. The feasibility of NGS on EUS-FNB samples has 
been demonstrated [22] and requires a tumour fraction≥20% either for pancreatic duct adenocarci-
noma (PDAC) [23] and pancreatic neuroendocrine tumors (pNETs) [24]. Therefore, EUS-FNB 
should guarantee a sample of adequate size and quality to perform molecular diagnostics.  
 
Up to now, no studies investigating the impact of different suction techniques on histological 
yield and sample quality of specimens from solid lesions using EUS-FNB needles have been pub-
lished. 
 
2. 
STUDY AIMS AND ENDPOINTS 
 
The primary aim of this study is to compare the histologic yield of EUS-FNB using the SP and the 
WS techniques. The primary endpoint is the rate of samples containing a tissue “core” (yes/no) for 
histological evaluation, defined as an intact piece of tissue of at least 550 μ [i.e., specimens scored 3 
using the tissue integrity score (see Table 1)]. The length of intact histological fragments will be 
measured by using dedicated software at each participating center. 
 
Secondary aims include: 
1) Sample quality in terms of tissue integrity and the blood contamination. A score will be applied 
according to Table 1 and outcomes using the two technique will be compared.   

6 
 
Table 1 
Sample quality scores (tissue integrity and blood contamination) 
SCORE  TISSUE INTEGRITY 
0 No cells/tissue  
1 Cytological specimen (disaggregated cells representative of the target lesion not allowing 
for tissue architectural assessment) 
2  Histologic microfragments (sample adequate for histological evaluation, namely an 
architecturally intact piece of tissue but without a “core”) 
3  Histologic “core” (defined as an architecturally intact piece of tissue measuring at least 
550 μ) 
SCORE  BLOOD CONTAMINATION 
0 Only blood  
1 High blood contamination (>50% of the surface) 
2 Moderate blood contamination (25-50% of the surface) 
3 Low blood contamination (<25% of the surface) 
 
 
2) Evaluation of tumor fraction with both techniques. The rate of samples collected with the two 
techniques containing an adequate tumor fraction ≥20% (i.e., ≥ 20% tumor cells in a background of 
benign nucleated cells) will be compared. Only PDAC and pNETs will be included for this aim. 
 
3) Diagnostic accuracy using two sampling technique, measured against the final diagnosis. The 
finals diagnosis will be assessed on surgical whenever available, and in non-resected patients will be 
based on the diagnostic work-up (combined outcomes of imaging studies and any additional biopsy 
sample result) and clinical course of the disease of at least 6 months. The Papanicolaou classification 
(Table 2, simplified) [25] will be used either for EUS-FNB samples and surgical pathology for pan-
creaticobiliary masses. Lymph nodes will be classified as benign or malignant. For the evaluation of 
submucosal lesions, GIST and neuroendocrine tumors will be considered as malignant. Immunohisto-
chemistry investigations will be performed, if required for diagnosis, as in normal clinical practice. 
 
 
 

7 
Table 2 
 Diagnostic category and diagnoses according to the Papanicolaou classification 
Diagnostic 
Category 
Sampling Features 
1 
Not adequate  
2 
Benign/neoplastic benign 
- chronic pancreatitis 
- autoimmune pancreatitis 
- intrapancreatic spleen 
- serous cystadenoma (solid type) 
- schwannoma 
3 
Atypical cells 
- Scant population of atypical cells of unclear origin 
4 
Neoplastic other 
- NET 
- solid pseudopapillary neoplasm 
- GIST 
5 
Suspicion for malignancy 
- Atypical cells suspicious for adenocarcinoma 
6 
Malignant 
- PDAC 
- neuroendocrine carcinoma 
- metastasis 
- other (specify) 
 
 
 
 
 
 
 
 
 
 
 

8 
3. 
PLAN OF INVESTIGATION 
 
 
Design of the study 
This is a multicenter, single-blind, randomized, controlled trial. All adult (≥ 18 years old) patients 
referred for EUS-FNB of solid lesions of the GI tract or adjacent to it will be assessed for eligibility. 
Patients with the following conditions will be included: 
§ 
Solid pancreatic lesions ³ 1cm 
§ 
Peri-GI tract lymph nodes ³ 1cm 
§ 
Peri-GI tract masses 
§ 
Lesions of the GI wall 
§ 
Signed informed consent 
 
Patients with the following conditions will be excluded:  
§ 
Pancreatic cystic lesions (more than 50% of the volume)  
§ 
Diameter of lesion ≤ 1 cm 
§ 
Lesion not seen at EUS 
§ 
Pregnancy 
§ 
Coagulopathy (platelet count <50.000/mm3 and/or international normalized ratio >1.5); 
§ 
Severe cardiorespiratory dysfunction precluding endoscopy;  
§ 
Failure to provide informed consent 
 
EUS-FNB procedures and samples processing 
All the procedures will be performed by experienced endosonographers at each center and 
using a linear echoendoscope. A 22G end-cutting needle (SharkCoreÔ or AcquireÔ) will be used in 
all cases. The choice between the SharkCore and the Acquire needle will be left to the endosonog-
rapher’s discretion or based on institutional disposition. 
Four passes will be performed [27] using the same needle alternating the sampling techniques 
(SP and WS). The sequence of will be assessed in a randomized fashion.   
For WS the stylet will be removed, and the needle will be pre-flushed with 1–2mL of saline. 
The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe 
[11]. The sample collected will be pushed into a formalin vial with saline.  
For SP, after puncturing the lesion, the stylet will be slowly and gradually withdrawn for at 
least 40cm. The sample will be pushed into formalin using the stylet.  

9 
Each pass, regardless of the sampling procedure, the fanning technique [28] will be used.  It 
consists of approximately 5-10 back-and-forth movements of the needle, positioned in different areas 
within the mass, by using the “up-down” dial of the echoendoscope and with minimal use of the 
elevator.. Afterwards, the needle will be withdrawn from the lesion.  
The sample taken during 1st/3rd passes and 2nd/4th passes will be placed in two separate vials 
containing formalin and processed as standard histology. The flowchart in Figure 1 illustrates the 
recruitment process. ROSE will be not used in any case.  
 
Drop out 
Patients will be not be considered included in the study in the following situations: 
§ 
Impossibility to perform EUS-FNB (e.g., for the interposition of vessels or technical failures).  
§ 
Impossibility to complete the procedure according to the protocol (e.g., it was not be possible 
to perform four needle passes). 
 
Randomization and blinding 
Once verified the eligibility to the trial, patients will be prospectively randomized in a 1:1 
ratio in a cross-over design within each center into one of two study groups based on a computer-
generated randomized blocks sequence (block size of 10) just before the procedure. Randomization 
will be stratified by type of lesion sampled (pancreatic versus other).  
A data manager not involved in the data analysis or patient enrollment will generate the ran-
domization lists and will prepare numerated sealed envelopes, containing the group assignment, that 
will be opened after study consent and EUS baseline assessment, just prior EUS-FNB. Patients will 
be randomly assigned into Group A and Group B in a 1:1 ratio. For Group A, the pass sequence is 
WS, SP, WS, SP. For Group B, the pass sequence is SP, WS, SP, WS.  
The pathologist designated for the evaluation of the samples will be blinded on the type of TA tech-
nique performed and randomization during the entire study. 
 
Follow-up 
Patients will be followed for at least 6 months, in order to assess the outcome of surgical resection 
or clinical course of the disease.  
 
 
 
 
 

10 
 
Figure 1. 
CONSORT flow-chart of the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consecutive patients with solid 
lesions referred for EUS-FNB 
will be assessed for eligibility 
Excluded  
- Pancreatic cystic lesions (more than 50% of the 
volume)  
- Diameter of lesion ≤ 1 cm 
- Lesion not seen at EUS 
- Pregnancy 
- Coagulopathy (platelet count <50.000/mm3 
and/or international normalized ratio >1.5); 
- Severe cardiorespiratory dysfunction precluding 
endoscopy;  
- Failure to provide informed consent 
Analysis Group A 
Allocation 
Analysis 
Follow-Up 
Group A (pass sequence 
WS, SP, WS, SP) 
Group B (pass sequence 
SP, WS, SP, WS) 
Randomization 
Drop-out 
- Impossibility to perform EUS-FNB (e.g., for the in-
terposition of vessels or technical failures). 
- Impossibility to complete the procedure according 
to the protocol 
 
Analysis Group B 
1st and 3rd pass 
Analysis Wet-Suction 
1st and 3rd pass 
2nd and 4th pass 
2nd and 4th pass 
Analysis Slow-pull 

11 
Collected data and data management 
The following data will be collected and included in a case record form (CRF) (see CRF attached): 
• 
Sex 
• 
Age 
• 
Technical success (Y/N) 
• 
Type of lesions (pancreatic/extrapancreatic/lymphnode) 
• 
Lesion location  
• 
EUS findings [site (e.g., head and size or the lesion), size (mm)] 
• 
Needle type used (SharkCore 22G or Acquire 22G) 
• 
Randomization (group A or B) 
• 
Number of passes performed 
• 
Fanning (Y/N) 
• 
Histological findings (Tissue Integrity score, Blood Contamination score, tumor fraction 
 
>20% for pancreatic cancer and NET) 
• 
Adverse events [29] 
• 
Diagnostic category on EUS-FNB for pancreatic lesions 
• 
Diagnosis for lymphnode (malignant/benign) 
• 
Diagnosis on EUS-FNB for submucosal lesions (specify) 
• 
Length (days) of the follow-up 
• 
Patient/lesion’s outcome at follow-up (death, weight loss/cachexia, surgery, lesion 
growth/infiltration/metastases appearance, lesion’s stable or disappearance with patient well) 
• 
Further sampling of the lesion (Y/N). 
• 
Final Diagnosis (specify; e.g.; PDAC, NET, GIST, Leiomyoma, Malignant Lymphnode) 
 
 
Enrollment and duration of study 
Enrollment will be competitive between centers and will extend for a maximum period of 9 
months after local Ethic Committee/IRB approval. It is plausible that Ethic Committee/IRB approval 
will be obtained at different time periods among the participating centers, thus requiring a total en-
rollment period of 18 months. A 6-month follow-up period is foreseen in order to evaluate the possi-
ble surgical treatment or other biopsy samplings or the evolution of the disease. We foresee a period 
of 3 months to complete the data analysis. The total duration of the study will be 27 months. 
 
 

12 
4. 
SAMPLE SIZE AND STATISTICAL ANALYSES 
 
Sample size calculation  
The sample size is calculated in the context of the primary binary outcome and considering 
the crossover design of the study with each lesion sampled with the two techniques. Assuming an 
expected pooled histological yield of 95% with WS [11] and 85% with SP [30,31] with α=0.05, 
power=0.9 and calculating the proportion of discordant pairs (equal to 0.18) with the approximation 
of Machin, Campbell, Fayers, and Pinol (1997) due to the lack of the data in the current literature, 
the total required sample size should be of 185 patients.  Assuming approximately 8% dropout rate, 
we calculated a final sample size of 200 patients.  
 
Statistical analyses 
The characteristics of the sample will be summarized by descriptive statistics (mean with stand-
ard deviation or median with interquartile range for continuous variables and frequency distributions 
for categorical variables).  
For the analysis of the primary end-point, the percentage of cases in which a histological sample 
was obtained will be calculated in each study arm. In particular, it will be possible to evaluate, for 
each group, through the McNemar test, if there is a statistically significant difference between the 
histological capacity of the two sampling techniques. 
 
Sample quality scores and rate of samples containing an adequate tumor fraction will be com-
pared using the McNemar test. Furthermore, the accuracy of the two techniques will be estimated by 
calculating sensitivity, specificity, positive predictive value, negative predictive value, and Area Un-
der the ROC Curve respect to the the final diagnosis. 
All analyses will be performed using the SPSS software with a statistical level of significance of 
5% and respective 95% confidence intervals. A two-tailed distribution will be used and statistically 
significance will be considered for P<0.05. 
 
5. 
ETHICAL CONSIDERATIONS 
 
Regulation statement 
The latest revision of the Helsinki declaration and the Declaration of Oviedo will be the basis for the 
ethical conduct of the study. This protocol will be designed and conducted to ensure adherence to the 
principles and procedures of the good clinical practice and comply with participants’ Country legis-
lations: 
1. ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996. 

13 
2. Directive 91/507/EEC, The Rules Governing Medicinal Products in the European 
Community. 
3. Directive 2001/20/EC 
4. Directive 2005/28/EC 
5. D. L.vo n.211 del 24 giugno 2003. 
6. D. L.vo n.200 6 Novembre 2007. 
7. D.M. 21 Dicembre 2007. 
 
Essential documents will be preserved to demonstrate the validity and integrity of the data collected. 
 
The Promoter of this study in accordance with the responsibilities provided for by the rules of good 
clinical practice (Legislative Decree 211/2003) and in compliance with the laws and regulations in 
force on data protection including the relevant European Regulation of personal data protection 
2016/679, will process the personal data collected, exclusively for the purpose of carrying out the 
study. 
 
 
 
Treatment and storage of biological samples 
 
Biological samples taken during EUS-FNB will be treated in each center as normal clinical practice, 
so for the study will not be performed any study-specific processing techniques or immunohistochem-
istry or samples’conservation. 
In particular, for the center of AOUI Verona, after FNB procedure, the sample will be transferred at 
the Pathology Division at the Department of diagnostic and Public Health, processed and analyzed 
according the current procedures normally used. The sample taken during the EUS-FNB, will be 
stored as usual. 
 
Recruitment and consent 
The treating physician will inform eligible patients about the study and will explain the aims, 
methods, anticipated benefits, and potential hazards at least 24 hours before. Also, this information 
will be provided in print. If patients have any further questions, they can also consult an independent 
physician. 
 

14 
Data management and procedures to guarantee the confidentiality of the data 
The promoter will undertake to observe the Privacy Laws (as following defined), included the parts 
relevant security procedures and privacy. The promoter guarantee, for himself and for the investiga-
tor, to be completely informed on all the obligations following any applicable regulation regards the 
professional secret in medical field and the protection of the patient's personal data, included in ex-
emplificative but not complete degree the guidelines UE 2016/679, the Privacy Code (D.Lgs 196/03, 
s.m.i.), the provisions, the guidelines and the current general authorizations of the Autorità Garante 
Italiana for the protection of personal data (collectively “Privacy Laws”). 
The promoter will undertake in order that its staff involved in the scientific study will respect the 
Privacy Laws and the Promoter's instructions on the protection of personal data, included security 
aspects and data confidentiality. This obligations includes, for example: (i) provide to the patient 
involved in the study a privacy informative according to law (UE guidelines 2016/679, D.Lgs. 
196/2003 s.m.i, nonetheless the above-mentioned guidelines delle 24 July 2008); (ii) obtain a written 
informed consent by the patient, before his involvement in the study; (iii) respect the privacy of every 
involved person as regulated by the Privacy Laws; (iv) adopt all the adequate physical, logical, or-
ganizational, technical and informatic measures to follow the appliable Privacy Laws.  
Due to the particular sensitivity of the data processed in the study, specific technical measures have 
been adopted to increase the level of data security, without prejudice to any other minimum measure. 
This, with particular reference to the registration operations with electronic and / or paper instruments 
of the data of the persons involved in the study at the testing centers, their transfer via e-mail to a 
single database at the subjects who perform, validation and processing data statistics and the man-
agement of the same database.  The promoter has adopted secure communication protocols based on 
the use of cryptographic standards for the electronic transmission of the data collected by the testing 
centers to the centralized database at the promoter or other subjects who carry out the subsequent 
validation and statistical processing of the data. In relation to these processing operations, the pro-
moter has taken appropriate measures to ensure the protection of data recorded by the risks of unau-
thorized access, theft or loss, partial or complete, of paper documents, storage media or portable or 
fixed processing systems (indicate, for example, through the partial or full application of crypto-
graphic technologies to file systems or databases, or through the adoption of other IT protection 
measures that make unintelligible data to uninformed subjects: "It is necessary to insert a username 
and a password to access the computers where the data are entered in. Furthermore, access to the 
database in order to start a data entry session is protected by a username and password. 
The following precautionary measures are taken to ensure data privacy and to prevent data manipu-
lation and loss: 

15 
i) Access to data is restricted to authorized members only. The authorized members are the research-
ers directly involved in the study (Stefano Francesco Crinò and Maria Cristina Conti Bellocchi) that 
will collect, analyse and interpret the data. 
ii) The network is protected by a firewall 
iii) Internet connection is encrypted with a digital certificate (SSL technology)  
iv) The database is on a server, password protected, which is changed periodically.  
v) Access to the database is password protected and is accessible only to those responsible for the 
center.  
vi) Periodic backups are performed. 
vii) places of conservation are protected (e.g., "The paper materials related to clinical evaluations will 
be stored in wardrobes, whose keys will be in possession only of the persons authorized by the persons 
in charge of the study). 
Finally, about the database, we will adopt a specific system for the authentication and authorization 
of the people involved in the study with different roles and the needs of access and suitable treatment 
and procedures for the periodic verification of the quality and consistency of the credential for the 
authentication of the profiles authorized assigned to the expert involved in the treatment.  
The experimenter will adequately separate the patients’ identification data from the results of the 
experiments (i.e., making anonymous those data by means of the individualization of the results with 
an alphanumeric code randomly generated) to allow the Promoter to analyze only pseudo-anonymous 
data.  
The promoter will allow access to the clinic data (including clinic files) and all the other information 
that can be relevant for the study, always observing the Privacy Law and respecting all the security 
measures and data confidence.  
Personal data of the subjects will be exclusively accessible for investigators and collaborators/co-
investigators, monitors and auditors of the Promoter, and/or for the competent authority encharged, 
in agreement with what is included in the Informed consent.  
The Promoter and the Investigator will make sure to inform the patients in a clear and thorough way 
about the modalities of personal data treatment before their participation to the experiment, as estab-
lished by the applicable Privacy Laws. 
Before data acquisition, the investigator will make sure to inform every patient about the nature, 
objectives, results, consequences and risks of the study before their participation in the study. Before 
recruitment, the investigator or an authorized delegate, will collect from the patient the written in-
formed consent to: a) participate in the study; b) communicate their own confidential information; c) 
the treatment of personal data; d) transfer the documents containing personal data of the patient, in-
cluding sensitive health data, to the Promoter and/or the authorities in charge and/or other institutions 

16 
including ones outside the European Union, in conformity to what is required by law and by the 
applicable Privacy Laws. 
The Promoter will make sure to keep the original paper documents (ex. informed consent) for at least 
7 years, in conformity with the dl200/2007. 
 
 
 
6. 
AUTHORSHIP RULES 
First and last authors will come from the centers of Verona and Roma. The number of Co-Au-
thors from collaborating centers will be assessed according to the number of patients included: less 
than 15 patients: one co-author; 15-30 patients: two co-authors; more than 30 patients: 3 co-authors.  
The research manager undertakes to protect the privacy of the participants in the study by 
processing the data exclusively for statistical and scientific research purposes and also undertakes not 
to communicate or spread them except in anonymous form. 
 
 

17 
7. 
REFERENCES 
      
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Erickson RA, Sayage-Rabie L, Beissner RS. Factors predicting the number of EUS-guided fine-
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Wani S. Basic techniques in endoscopic ultrasound-guided ﬁne needle aspiration: Role of a stylet 
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Oppong KW. Comparison of the diagnostic performance of 2 core biopsy needles for EUS-
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