Clinical trial NCT05825729: Diagnostic Efficacy Of 3 EUS-FNB Techniques
Official title: Diagnostic Efficacy Of 3 Endoscopic Ultrasound-Guided Fine Needle Biopsy Techniques In Solid Masses: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Efficacy, Self
Keywords: endoscopic ultrasound
solid masses
fine needle biopsy
Lead sponsor: Hospital Universitario Insular Gran Canaria
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicentric, randomized comparative clinical trial, single-blind and crossover.
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound (EUS) is a widely recognized tool for over 30 years for diagnosing intra-abdominal lesions and gastrointestinal cancers, especially pancreatic neoplasia. In most hospitals, it is the preferred method for sampling using fine-needle aspiration (EUS-FNA) or histology needle aspiration biopsy (EUS-FNB) to obtain cytological and histological material for an anatomopathological diagnosis. It is also recognized by current oncology guidelines.

Numerous factors can affect the efficacy of this technique, such as the needle size, type (cytology or histology), number of passes made on the lesion, the presence or absence of a pathologist in the endoscopy room, the experience of the endoscopist, etc.

Currently, EUS-FNA or EUS-FNB are recommended interchangeably for diagnosis; however, it appears that histology needles (EUS-FNB) allow for greater diagnostic efficacy by obtaining a cellular block with fewer passes, which allows for more advanced anatomopathological analysis (such as immunohistochemistry or molecular analysis).

Regarding the technique for performing the puncture and acquiring the sample, current European guidelines recommend sampling using EUS-FNA or FNB by dry suction with a 10 mL syringe. However, other recognized techniques, such as using a stylet with the "slow-pull" technique (not positioning for or against) or liquid biopsy (which could obtain larger cellular blocks compared to dry puncture), are widely used and could obtain better samples, but there is no clear consensus currently.

Investigators' goal is to conduct a randomized clinical trial of three EUS-FNB techniques (dry puncture vs slow-pull vs wet puncture) used in daily clinical practice to evaluate which of the three techniques has greater efficacy in cytological and pathological diagnosis.


Eligibility criteria: Inclusion criteria

* Age ≥ 18 years
* Patients referred for EUS-FNB after imaging tests (CT, MRI, or abdominal ultrasound) of pancreatic, non-pancreatic intraabdominal, mediastinal, or pelvic lesions greater than 1 cm.
* Signed informed consent.

Exclusion criteria

* Coagulopathy (INR\> 1.5) or thrombocytopenia (\<50,000)
* Severe heart or respiratory failure that contraindicates sedation.
* Use of anticoagulants and antiplatelet agents that cannot be suspended.
* Use of a needle of a different gauge to 22G
* Refusal to sign informed consent.

Primary outcomes:
measure: Diagnostic Efficacy
timeFrame: 2 years
measure: Quality of samples
timeFrame: 2 years
Secondary outcomes:
measure: Rapid On Site Evaluation (ROSE)
timeFrame: 2 years
measure: Endoscopist's experience
timeFrame: 2 years
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Doctor Negrin de Gran Canaria
state: Las Palmas
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Materno Infantil
state: Las Palmas
Study officials:
affiliation: CHUIMI
name: Guillermo Perez-Aguado, MD
role: PRINCIPAL_INVESTIGATOR
References: