Efficacy, SelfPhase 4NCT05825729
Diagnostic Efficacy Of 3 EUS-FNB Techniques
A Phase 4 study testing Dry suction technique (A), Slow-pull technique (B) and Wet suction technique (C) in people with Efficacy, Self, run by Hospital Universitario Insular Gran Canaria at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Efficacy, Self
- What is being tested?
- Dry suction technique (A), Slow-pull technique (B) and Wet suction technique (C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesSpain
- Study dates
- 27 Jun 2023to 22 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Doctor Negrin de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35010
Maria Lorente Arencibia, MD
Maria Lorente Arencibia, MD
- Recruiting
Complejo Hospitalario Universitario Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, 35016
Guillermo Pérez-Aguado, MD
Guillermo Perez Aguado, MD
About this study
Official title: Diagnostic Efficacy Of 3 Endoscopic Ultrasound-Guided Fine Needle Biopsy Techniques In Solid Masses: A Randomized Clinical Trial
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.
Read more
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
- Being tested
- Dry suction technique (A), Slow-pull technique (B), Wet suction technique (C)
- Keywords
- endoscopic ultrasound, solid masses, fine needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry suction technique (A)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)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)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.
| Study group | Role | What they receive |
|---|---|---|
| ABC | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
| ACB | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
| BAC | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
| BCA | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
| CAB | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
| CBA | Active comparator | 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 Receives: Diagnostic Test: Dry suction technique (A); Diagnostic Test: Slow-pull technique (B); Diagnostic Test: Wet suction technique (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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%
Measured: 2 years
Secondary outcomes (2)
Rapid On Site Evaluation (ROSE)
Impact of the presence of ROSE on the different EUS-FNB techniques
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start27 Jun 2023
- Primary completion22 May 2025 (estimated)
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy, SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicentric, randomized comparative clinical trial, single-blind and crossover.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Insular Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Pérez Aguado, Hospital Universitario Insular Gran Canaria
- Investigators
- Guillermo Perez-Aguado, MD, Principal investigator, CHUIMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825729
- Sponsor's protocol ID
- TEC-EUS
- Status last verified
- Nov 2023
- First submitted
- 22 Mar 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficacy Of 3 Endoscopic Ultrasound-Guided Fine Needle Biopsy Techniques In Solid Masses: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05825729
- Acronym / sponsor ID
- TEC-EUS
- Conditions
- Efficacy, Self
- Keywords
- endoscopic ultrasound, solid masses, fine needle biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hospital Universitario Insular Gran CanariaUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 22 May 2025 (estimated)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Multicentric, randomized comparative clinical trial, single-blind and crossover.
| Arm | Type | Receives |
|---|---|---|
| ABC | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
| ACB | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
| BAC | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
| BCA | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
| CAB | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
| CBA | Active comparator | Diagnostic Test: Dry suction technique (A), Diagnostic Test: Slow-pull technique (B), Diagnostic Test: Wet suction technique (C)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | ABC, ACB, BAC, BCA, CAB, CBA |
| 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. | Diagnostic test | ABC, ACB, BAC, BCA, CAB, CBA |
| 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. | Diagnostic test | ABC, ACB, BAC, BCA, CAB, CBA |
Primary outcome
Diagnostic Efficacy
Time frame: 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
Time frame: 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%
2 secondary outcomes
Rapid On Site Evaluation (ROSE)
Time frame: 2 years
Endoscopist's experience
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Perez-Aguado, MD principal investigator
CHUIMI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dry suction technique (A), Slow-pull technique (B) and Wet suction technique (C) in people with Efficacy, Self, run by Hospital Universitario Insular Gran Canaria at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Perez-Aguado, MD (+34647369686, guiperez92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Efficacy (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.