Clinical trial · Interventional
EUS-FNB for Solid Pancreatic Lesions: Side-fenestrated Vs Fork-tip Needle
Single Center Randomized Clinical Trial to Evaluate the Histological and Diagnostic Accuracy of Two EUS Fine Needles Biopsy for the Diagnosis of Solid Pancreatic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rationale: Until now there are no prospective studies comparing the 22 gauge and 25 gauge side-fenestrated and fork-tip needles. In the present study we will compare the two types of needles in terms of histological yield for the evaluation of solid pancreatic lesions in the absence of rapid on-site evaluation (ROSE). Moreover diagnostic accuracy and the number of passes necessary to achieve the maximum diagnostic and histological yield, and safety will be investigated. Objectives: To evaluate and compare the histologic retrieval rate of two different EUS-FNB needles of the same caliber (22 or 25 gauge). The passes will be 3 for each patient. Study design: Randomized monocentric trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling of a solid pancreatic mass. Intervention: EUS-guided tissue acquisition by mean EUS-FNB, using one of the following FNB needles: side-fenestrated 22 gauge, side-fenestrated 25 gauge, fork-tip 22 gauge or fork-tip 25 gauge. Main study parameters/endpoints: The main endpoint is the histologic yield (defined as the percentage of a tissue core of at least 550 micron at the greatest axis), obtained at each of the 3 needle passes. Secondary endpoints include: i) safety; ii) concordance between macroscopic on-site evaluation (MOSE) and histopathological evaluation ; iii) Accuracy using 1, 2 or 3 passes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy, Fine-needle | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histologic evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNB with side-fenestrated needle
- description
- Before randomization, the endosonographer chooses the needle gauge to perform biopsy preferring the 25 gauge caliber for "difficult" lesions. The needle advances inside the lesion and the operator will perform some needle movements back and forth into the lesion while slowly withdrawn the stylet (slow-pull technique). If possible the direction of the needle inside the lesion will be changed during the movements (fanning technique) to sample different areas of the lesion. Three needle passes will be performed and the material acquired at each pass will be placed directly in formalin in a single vial. Diagnostic Test: Histologic evaluation
- interventionNames
- Diagnostic Test: Histologic evaluation
- type
- ACTIVE_COMPARATOR
- label
- EUS-FNB with fork-tip needle
- description
- Intervention: like above. Diagnostic Test: Histologic evaluation.
- interventionNames
- Diagnostic Test: Histologic evaluation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Solid pancreatic mass referred for EUS-guided tissue acquisition. * Written informed consent. Exclusion Criteria: * Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP). * Cystic lesions even with solid component. * Previous inclusion in present study. * Previous histological or cytological diagnosis. * Pancreatic lesion not seen at EUS. * Technical impossibility to perform EUS-FNB (for example, for the interposition of vessels). * Patients in an emergency situation. * Pregnancy or feeding time.
References
Publications (1)
- DERIVEDCrino SF, Le Grazie M, Manfrin E, Conti Bellocchi MC, Bernardoni L, Granato A, Locatelli F, Parisi A, Di Stefano S, Frulloni L, Larghi A, Gabbrielli A. Randomized trial comparing fork-tip and side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions. Gastrointest Endosc. 2020 Sep;92(3):648-658.e2. doi: 10.1016/j.gie.2020.05.016. Epub 2020 May 17. PMID 32433914