Clinical trial · Interventional
22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions
22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions: a Randomized Controlled Study
NCT06563232CI-TRIAL-00079947unknownN/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 multicenter randomized controlled study to evaluate the diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology 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 |
|---|---|---|---|
| Adapt FNB group | Device | — | UNRESOLVED |
| FNA group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FNA group
- description
- FNA needles adopted to acquire lesion tissues
- interventionNames
- Device: FNA group
- type
- EXPERIMENTAL
- label
- Adapt FNB group
- description
- Adapt FNB needles adopted to acquire lesion tissues
- interventionNames
- Device: Adapt FNB group
Primary outcomes (1)
- measure
- The histological diagnostic yields
- timeFrame
- up to 15 months
- description
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; * Imaging examinations (MRI, CT, B-ultrasound) reveal the presence of solid masses (with a diameter \> 1 cm) within the regions accessible by endoscopic ultrasound in the pancreas, peripancreatic area, liver, adrenal gland, kidney, mediastinum, lung, and gastrointestinal submucosa. Biopsy is necessary for the diagnosis of these lesions; * 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 (PLT \<50,000/mm3,INR \> 1.5); * Took anticoagulants such as aspirin, warfarin in the latest week; * Acute pancreatitis in the past two weeks; * inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.
References
Publications (7)
- 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
- RESULTCheng B, Zhang Y, Chen Q, Sun B, Deng Z, Shan H, Dou L, Wang J, Li Y, Yang X, Jiang T, Xu G, Wang G. Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19. PMID 28733257
- RESULTPouw RE, Barret M, Biermann K, Bisschops R, Czako L, Gecse KB, de Hertogh G, Hucl T, Iacucci M, Jansen M, Rutter M, Savarino E, Spaander MCW, Schmidt PT, Vieth M, Dinis-Ribeiro M, van Hooft JE. Endoscopic tissue sampling - Part 1: Upper gastrointestinal and hepatopancreatobiliary tracts. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Nov;53(11):1174-1188. doi: 10.1055/a-1611-5091. Epub 2021 Sep 17. PMID 34535035
- RESULTItonaga M, Yasukawa S, Fukutake N, Ogura T, Asada M, Shimokawa T, Inatomi O, Nakai Y, Shiomi H, Nebiki H, Suzuki A, Kitagawa K, Asai S, Shimatani M, Sanuki T, Kurita A, Takenaka M, Yoshida M, Hoki N, Yasuda H, Maruyama H, Matsumoto H, Yanagisawa A, Kitano M. Comparison of 22-gauge standard and Franseen needles in EUS-guided tissue acquisition for diagnosing solid pancreatic lesions: a multicenter randomized controlled trial. Gastrointest Endosc. 2022 Jul;96(1):57-66.e2. doi: 10.1016/j.gie.2022.02.005. Epub 2022 Feb 11.