22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions

NCT06563232 | Not Yet Recruiting DMC

• 1 other identifier: FNA vs Adapt FNB
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

endoscopic ultrasound; fine-needle aspiration; fine-needle biopsy

Outcome Measures

Primary Outcomes (1)

• The histological diagnostic yields

  The investigators' primary outcome measure is to compare the histological diagnostic yields of 22G Adapt Aspiration FNB and FNA puncture needle (22G EchoTip Ultra Echo-3-22) to the solid pancreatic or nonpancreatic lesions compared to conventional FNA puncture needle(22G EchoTip Ultra Echo-3-22) for pancreatic and non-pancreatic solid lesions.

  up to 15 months

Secondary Outcomes (4)

• the histological acquisition yields

  up to 15 months

• the diagnostic yields of the first pass and the number of subsequent passes

  up to 15 months

• the cytological diagnosis yields

  up to 15 months

• the complication yields

  up to 15 months

Study Arms (2)

FNA group

EXPERIMENTAL

FNA needles adopted to acquire lesion tissues

Device: FNA group

Adapt FNB group

EXPERIMENTAL

Adapt FNB needles adopted to acquire lesion tissues

Device: Adapt FNB group

Interventions

FNA group DEVICE

Fine-needle-aspiration (22G EchoTip Ultra Echo-3-22)

FNA group

Adapt FNB group DEVICE

Fine-needle-biopsy (22G Adapt Aspiration)

Adapt FNB 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Peking Union Medical College Hospital: collaborator
• Fudan University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Chongqing University Cancer Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Itonaga 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.

  PMID: 35151711 RESULT

• 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 RESULT

• 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 RESULT

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

Qingxiong Ma

CONTACT

+8613588580316; u202110372@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: August 17, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CN (1)