22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions

NCT07012694 | Not Yet Recruiting DMC

• 1 other identifier: Franseen FNB vs Adapt FNB 2025
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Neoplasms; Mediastinal Neoplasms; Abdominal Neoplasm, Excluding Pancreas Neoplasm

Keywords

Endoscopic ultrasound; Fine-needle biopsy

Outcome Measures

Primary Outcomes (1)

• The histological diagnostic yields

  The primary outcome measure of the study is to compare the histological diagnostic yield of EUS-guided fine-needle biopsy (EUS-FNB) using a 22G Franseen needle versus a 22G Adapt needle for both pancreatic and non-pancreatic solid lesions.

  up to 15 months

Secondary Outcomes (3)

• The histological acquisition yields

  up to 15 months

• The cytological diagnosis yields

  up to 15 months

• The Immunohistochemical (IHC) staining success rate

  up to 15 months

Study Arms (2)

22G Franseen Needle Group

EXPERIMENTAL

22G Franseen needles were adopted to acquire lesion tissues

Device: 22G Franseen Needle Group

22G Adapt Needle Group

EXPERIMENTAL

22G Adapt needles were adopted to acquire lesion tissues

Device: 22G Adapt Needle Group

Interventions

22G Franseen Needle Group DEVICE

Fine-needle-biopsy (22G Franseen, Boston Scientific, Winston-Salem, USA)

22G Franseen Needle Group

22G Adapt Needle Group DEVICE

Fine-needle-biopsy (22G Adapt, Micro.Tech Endoscopy, Nanjing, China)

22G Adapt Needle Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The First People's Hospital of Yunnan: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (12)

• Gkolfakis 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 BACKGROUND

• van 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 BACKGROUND

• Facciorusso 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 BACKGROUND

• Kovacevic 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 BACKGROUND

• Ashat 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 BACKGROUND

• 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.

  PMID: 31654634 BACKGROUND

• Pouw 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 BACKGROUND

• Cheng 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 BACKGROUND

• Oh D, Kong J, Ko SW, Hong SM, So H, Hwang JS, Song TJ, Lee SK, Kim MH, Lee SS. A comparison between 25-gauge and 22-gauge Franseen needles for endoscopic ultrasound-guided sampling of pancreatic and peripancreatic masses: a randomized non-inferiority study. Endoscopy. 2021 Nov;53(11):1122-1129. doi: 10.1055/a-1369-8610. Epub 2021 Mar 2.

  PMID: 33652495 BACKGROUND

• Gerke H, Rizk MK, Vanderheyden AD, Jensen CS. Randomized study comparing endoscopic ultrasound-guided Trucut biopsy and fine needle aspiration with high suction. Cytopathology. 2010 Feb;21(1):44-51. doi: 10.1111/j.1365-2303.2009.00656.x. Epub 2009 May 18.

  PMID: 19456845 BACKGROUND

• Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.

  PMID: 23433878 BACKGROUND

• Crino SF, Conti Bellocchi MC, Di Mitri R, Inzani F, Rimbas M, Lisotti A, Manfredi G, Teoh AYB, Mangiavillano B, Sendino O, Bernardoni L, Manfrin E, Scimeca D, Unti E, Carlino A, Voiosu T, Mateescu RB, Fusaroli P, Lega S, Buscarini E, Pergola L, Chan SM, Lamonaca L, Gines A, Fernandez-Esparrach G, Facciorusso A, Larghi A. Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial. Endoscopy. 2023 Mar;55(3):225-234. doi: 10.1055/a-1915-1812. Epub 2022 Aug 1.

  PMID: 35915956 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Mediastinal Neoplasms; Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Thoracic Neoplasms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Study Officials

• Bin Cheng

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng

CONTACT

+8613986097542; b.cheng@tjh.tjmu.edu.cn

Yanyan Zhang

CONTACT

+8613525031377; d202482516@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)