Clinical trial · Interventional
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
A Prospective, Multicenter, Blinded, Randomized Controlled Trial Assessing the Diagnostic Yield and Tissue Adequacy of 22G Adapt Versus 22G Franseen Fine-Needle Biopsy for Solid Lesions Under Endoscopic Ultrasound Guidance
NCT07012694CI-TRIAL-00091622not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The investigators conduct a prospective, multicenter, blinded, randomized controlled trial to compare the diagnostic value and safety of the 22G Adapt needle versus the 22G Franseen needle for histopathological evaluation of solid lesions.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm, Excluding Pancreas Neoplasm | — | UNRESOLVED | — |
| Mediastinal Neoplasms | Mediastinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 22G Adapt Needle Group | Device | — | UNRESOLVED |
| 22G Franseen Needle Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 22G Franseen Needle Group
- description
- 22G Franseen needles were adopted to acquire lesion tissues
- interventionNames
- Device: 22G Franseen Needle Group
- type
- EXPERIMENTAL
- label
- 22G Adapt Needle Group
- description
- 22G Adapt needles were adopted to acquire lesion tissues
- interventionNames
- Device: 22G Adapt Needle Group
Primary outcomes (1)
- measure
- The histological diagnostic yields
- timeFrame
- up to 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old and under 85 years old; * Presence of a solid lesion greater than 1 cm in diameter, as identified by cross-sectional imaging (Magnetic Resonance Imaging, Computed Tomography or abdominal ultrasound), located in anatomical regions accessible via endoscopic ultrasound (EUS)-including but not limited to the pancreas, retroperitoneum, liver, mediastinum, or subepithelial layers of the gastrointestinal tract-where tissue acquisition is clinically indicated to establish a definitive histopathological diagnosis.; * Must be able to receive examinations in the research center; * Must be able to sign the informed consent. Exclusion Criteria: * Hemoglobin ≤8.0 g/dL; * Pregnant women; * Coagulation disorders(Platelet \<50,000/mm3, International Normalized Ratio \> 1.5); * Took anticoagulants such as aspirin, warfarin in the latest week; * Acute pancreatitis in the past two weeks; * inability to safely perform Endoscopic Ultrasound-Guided Tissue Acquisition (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
References
Publications (12)
- RESULTGkolfakis P, Crino SF, Tziatzios G, Ramai D, Papaefthymiou A, Papanikolaou IS, Triantafyllou K, Arvanitakis M, Lisotti A, Fusaroli P, Mangiavillano B, Carrara S, Repici A, Hassan C, Facciorusso A. Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis. Gastrointest Endosc. 2022 Jun;95(6):1067-1077.e15. doi: 10.1016/j.gie.2022.01.019. Epub 2022 Feb 4. PMID 35124072
- RESULTvan Riet PA, Erler NS, Bruno MJ, Cahen DL. Comparison of fine-needle aspiration and fine-needle biopsy devices for endoscopic ultrasound-guided sampling of solid lesions: a systemic review and meta-analysis. Endoscopy. 2021 Apr;53(4):411-423. doi: 10.1055/a-1206-5552. Epub 2020 Aug 6. PMID 32583392
- RESULTFacciorusso A, Arvanitakis M, Crino SF, Fabbri C, Fornelli A, Leeds J, Archibugi L, Carrara S, Dhar J, Gkolfakis P, Haugk B, Iglesias Garcia J, Napoleon B, Papanikolaou IS, Seicean A, Stassen PMC, Vilmann P, Tham TC, Fuccio L. Endoscopic ultrasound-guided tissue sampling: European Society of Gastrointestinal Endoscopy (ESGE) Technical and Technology Review. Endoscopy. 2025 Apr;57(4):390-418. doi: 10.1055/a-2524-2596. Epub 2025 Feb 27. PMID 40015316
- RESULTKovacevic B, Toxvaerd A, Klausen P, Larsen MH, Grutzmeier S, Detlefsen S, Karstensen JG, Brink L, Hassan H, Hogdall E, Vilmann P. Tissue amount and diagnostic yield of a novel franseen EUS-FNB and a standard EUS-FNA needle-A randomized controlled study in solid pancreatic lesions. Endosc Ultrasound. 2023 May-Jun;12(3):319-325. doi: 10.1097/eus.0000000000000007. Epub 2023 Jul 25. PMID 37693112
- RESULTAshat M, Klair JS, Rooney SL, Vishal SJ, Jensen C, Sahar N, Murali AR, El-Abiad R, Gerke H. Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy. Gastrointest Endosc. 2021 Jan;93(1):140-150.e2. doi: 10.1016/j.gie.2020.05.057. Epub 2020 Jun 9. PMID 32526235
- Kurita A, Yasukawa S, Zen Y, Yoshimura K, Ogura T, Ozawa E, Okabe Y, Asada M, Nebiki H, Shigekawa M, Ikeura T, Eguchi T, Maruyama H, Ueki T, Itonaga M, Hashimoto S, Shiomi H, Minami R, Hoki N, Takenaka M, Itokawa Y, Uza N, Hashigo S, Yasuda H, Takada R, Kamada H, Kawamoto H, Kawakami H, Moriyama I, Fujita K, Matsumoto H, Hanada K, Takemura T, Yazumi S. Comparison of a 22-gauge Franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study). Gastrointest Endosc. 2020 Feb;91(2):373-381.e2. doi: 10.1016/j.gie.2019.10.012. Epub 2019 Oct 22.