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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
Complejo Hospitalario Universitario Materno Infantil
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Doctor Negrin de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Contact Information
Primary
Guillermo Perez-Aguado, MD
guiperez92@gmail.com
+34647369686
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2025-05-22
Participants
Target number of participants: 330
Treatments
Active_comparator: 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
Active_comparator: 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
Active_comparator: 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
Active_comparator: 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
Active_comparator: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario Insular Gran Canaria

This content was sourced from clinicaltrials.gov

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