Diagnostic Efficacy Of 3 EUS-FNB Techniques

Phase 4

Recruiting

• Conditions: Efficacy, Self

• Registration Number: NCT05825729
• Lead Sponsor: Hospital Universitario Insular Gran Canaria

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Study Start: 2023-06-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2025-05-22
• Study Completion: 2025-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Diagnostic Efficacy	2 years	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.
Quality of samples	2 years	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%

Secondary Outcome Measures

Name	Time	Method
Rapid On Site Evaluation (ROSE)	2 years	Impact of the presence of ROSE on the different EUS-FNB techniques
Endoscopist's experience	2 years	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

Trial Locations

Locations (2)

Hospital Universitario Doctor Negrin de Gran Canaria; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain

Complejo Hospitalario Universitario Materno Infantil; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain