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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-04-01

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.

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Detailed Description

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Conditions

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Biopsy, Fine-Needle Endosonography Pancreatic Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EUS-guided FNB with syringe suction

Group Type EXPERIMENTAL

EUS-guided FNB with Syringe Suction

Intervention Type DEVICE

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.

EUS-guided FNB without syringe suction

Group Type ACTIVE_COMPARATOR

EUS-guided FNB without Syringe Suction

Intervention Type DEVICE

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.

Interventions

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EUS-guided FNB with Syringe Suction

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.

Intervention Type DEVICE

EUS-guided FNB without Syringe Suction

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No