Diagnostic Efficacy Of 3 EUS-FNB Techniques

Efficacy, Self Clinical Trial

Official title:

Diagnostic Efficacy Of 3 Endoscopic Ultrasound-Guided Fine Needle Biopsy Techniques In Solid Masses: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825729
• Other study ID #: TEC-EUS
• Status: Recruiting
• Phase: Phase 4
• Start date: June 27, 2023
• Est. completion date: May 22, 2025

Study information

• Verified date: November 2023
• Source: Hospital Universitario Insular Gran Canaria
• Contact: Guillermo Perez-Aguado, MD
• Phone: +34647369686
• Email: guiperez92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: May 22, 2025
• Est. primary completion date: May 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy, Self

Intervention

Diagnostic Test:
• Dry suction technique (A)
Using a linear echoendoscope, such as Pentax or Olympus, after identifying the lesion and deciding where to perform the EUS-FNB, always checking that there are no vessels on the eco-Doppler that would prevent puncture, a 22G Cook "Echo-Tip Procore" histology needle will be used to perform the following techniques of the described arms. - Dry suction puncture: Once the lesion is located and punctured, the stylet will be completely removed, and a 10 mL syringe with a vacuum of 10 mL will be attached. In each pass, the needle will be advanced and retracted 20-30 times according to the standard technique. The suction will then be closed, and the needle will be removed. The "fanning" technique will be performed whenever possible.
• Slow-pull technique (B)
Using a linear echoendoscope, such as Pentax or Olympus, after identifying the lesion and deciding where to perform the EUS-FNB, always checking that there are no vessels on the eco-Doppler that would prevent puncture, a 22G Cook "Echo-Tip Procore" histology needle will be used to perform the following techniques of the described arms.
• Wet suction technique (C)
Using a linear echoendoscope, such as Pentax or Olympus, after identifying the lesion and deciding where to perform the EUS-FNB, always checking that there are no vessels on the eco-Doppler that would prevent puncture, a 22G Cook "Echo-Tip Procore" histology needle will be used to perform the following techniques of the described arms. - Wet suction technique: Prior to puncture, the stylet should be removed and the needle should be flushed with 1-2 ml of physiological saline and a 10 ml vacuum syringe with 3-5 ml of saline should be attached. In each pass, the needle should be moved forward and backward 20-30 times. Aspiration should be opened as the needle advances and closed as it is withdrawn. Afterwards, the aspiration should be closed and the needle should be removed. The "fanning" technique should be performed whenever possible.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Materno Infantil	Las Palmas De Gran Canaria	Las Palmas
Spain	Hospital Universitario Doctor Negrin de Gran Canaria	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Insular Gran Canaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Efficacy	Analyze the diagnostic efficacy of the three techniques used in obtaining echoendoscopic biopsies of solid lesions: Slow-pull vs EUS-FNB with standard dry aspiration vs EUS-FNB with wet aspiration.; The diagnostic efficacy will be evaluated in terms of sensibility, specificity, positive predictive value and negative predictive value.	2 years
Primary	Quality of samples	Tissue integrity A: presence of tissue cylinder (intact piece of tissue measuring at least 550 microns in the microscope field of view).B: presence of tissue cylinder that does not meet criteria but allows for a diagnosis based on cellular morphology.C: No viable intact tissue exists.Cellularity A: Satisfactory, presence of > 4 clusters suitable for cytological interpretation with a minimum of 10 cells.B: Adequate, presence of 2-4 clusters suitable for cytological interpretation with a minimum of 10 cells.C: Inadequate, < 2 clusters suitable for cytological interpretation or non-representative sample or a cell count < 50 with clear nuclear structures.Blood presence A: Minimal contamination, erythrocytes in < 25% B: Moderate contamination, erythrocytes in 25-50% C: Significant contamination, erythrocytes in > 50%	2 years
Secondary	Rapid On Site Evaluation (ROSE)	Impact of the presence of ROSE on the different EUS-FNB techniques	2 years
Secondary	Endoscopist's experience	Evaluate the influence of the endoscopist's experience on the results of the three techniques. The experience of the endoscopic investigator will be based on the number of procedures divided in: more than 500 EUS-FNB, between 500-250 EUS-FNB and less than 250 EUS-FNB	2 years