Diagnostic Efficacy Of 3 EUS-FNB Techniques

NCT ID: NCT05825729

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2025-05-22

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.

Conditions

Efficacy, Self

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

ABC

The arms of the study are just the order of the interventions are performed

1. º Dry suction technique

2. º Slow pull technique

3. º Wet suction technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

ACB

The arms of the study are just the order of the interventions are performed

1. º Dry suction technique

2. º Wet suction technique

3. º Slow pull technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

BAC

The arms of the study are just the order of the interventions are performed 2º Slow pull technique

1º Dry suction technique 3º Wet suction technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

BCA

The arms of the study are just the order of the interventions are performed

1. º Slow pull technique

2. º Wet suction technique

3. º Dry suction technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

CAB

The arms of the study are just the order of the interventions are performed

1. º Wet suction technique

2. º Dry suction technique

3. º Slow pull technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

CBA

The arms of the study are just the order of the interventions are performed

1. º Wet suction technique

2. º Slow pull technique

3. º Dry suction technique

Group Type: ACTIVE_COMPARATOR

Dry suction technique (A)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitario Insular Gran Canaria

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Pérez Aguado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Perez-Aguado, MD

Role: PRINCIPAL_INVESTIGATOR

CHUIMI

Locations

Hospital Universitario Doctor Negrin de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status: RECRUITING

Complejo Hospitalario Universitario Materno Infantil

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Guillermo Perez-Aguado, MD

Role: CONTACT

guiperez92@gmail.com

+34647369686

Facility Contacts

Maria Lorente Arencibia, MD

Role: primary

Guillermo Pérez-Aguado, MD

Role: primary

Other Identifiers

TEC-EUS

Identifier Type: -

Identifier Source: org_study_id