Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions

Study Overview
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Brief Summary
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Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized. Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used. Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction. The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB. For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis. Clinical care during and after the procedure will follow the existing guidelines. Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.

Official Title
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Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction

Conditions
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Biopsy, Fine-Needle, Endosonography, Pancreatic Neoplasm

Intervention / Treatment
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* Device: EUS-guided FNB with Syringe Suction
* Device: EUS-guided FNB without Syringe Suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with 18 years of age and older; Ability to provide free and informed consent before entering the study; Imaging diagnosis of a solid pancreatic lesion that was proposed for EUS characterization; Presence of sectional imaging method (CT/MRI) performed within six months before randomization; Blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers; Clinical indication by the endoscopist for EUS-tissue acquisition with the use of an FNB needle. Exclusion Criteria: Failure to provide free and informed consent; Clinically significant change in haemostasis laboratory parameters: International Normalized Ratio (INR) > 1.5; activated partial thromboplastin time (aPTT)> 50 seconds; Platelets <50,000; Absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of FNB; Absence of fasting (2h without clear liquids and 6h without solid foods); Clinical suspicion of upper digestive tract obstruction; An episode of acute pancreatitis within four weeks before echoendoscopy; Respiratory failure or hemodynamic instability; Pregnancy or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-guided FNB with syringe suction<br> | Device: EUS-guided FNB with Syringe Suction<br>* For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.<br>|
| Active Comparator: EUS-guided FNB without syringe suction<br> | Device: EUS-guided FNB without Syringe Suction<br>* For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield | Percentage of the lesions sampled for which a tissue diagnosis is obtained and specimen adequacy is defined as the percentage of lesions sampled in which the obtained material is representative of the target site and sufficient for diagnosis | Through study completion, an average of 10 months | 
| Accuracy | Percentage of lesions sampled by EUS-tissue aquisition techniques that correspond to the final diagnosis at surgical histopathology or clinical follow-up (at least 12 months) for patients with nondiagnostic sampling. | Through study completion, an average of 10 months |