Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device

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ClinicalTrials.gov Identifier: NCT03803930

Recruitment Status : Unknown

Verified January 2019 by Bin Cheng, Huazhong University of Science and Technology.
Recruitment status was: Not yet recruiting

First Posted : January 15, 2019

Last Update Posted : January 17, 2019

Sponsor:

Information provided by (Responsible Party):

Bin Cheng, Huazhong University of Science and Technology

Study Description

Brief Summary:

The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.

Condition or disease	Intervention/treatment	Phase
Pancreas Neoplasms	Device: Using 22G FNB, the first pass is SP Device: Using 22G FNB, the first pass is MWST Device: Using 20G FNB, the first pass is SP Device: Using 20G FNB, the first pass is MWST	Not Applicable

Detailed Description:

This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1224 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device for Solid Pancreatic Lesions: a Prospective Multi-center, Randomized, and Controlled Trial
Estimated Study Start Date :	March 1, 2019
Estimated Primary Completion Date :	June 1, 2020
Estimated Study Completion Date :	August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Arm 22G+SP Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.	Device: Using 22G FNB, the first pass is SP Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm 22G+MWST Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.	Device: Using 22G FNB, the first pass is MWST Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Arm 20G+SP Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.	Device: Using 20G FNB, the first pass is SP Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm 20G+MWST Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.	Device: Using 20G FNB, the first pass is MWST Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.

Outcome Measures

Primary Outcome Measures :

The diagnostic yields [ Time Frame: up to 15 months ]
The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.

Secondary Outcome Measures :

the tissue integrity [ Time Frame: up to 15 months ]
The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >18 years old,<85 years old;
Gender: Male or Female;
Presence solid occupying pancreatic lesions (the diameter>1cm);
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;
Took anticoagulants such as aspirin, warfarin in the latest week;
Acute pancreatitis in the past two weeks;
Cardiopulmonary dysfunction;
Cannot sign the informed consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803930

Contacts

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Contact: Bin Cheng	+862783663333	b.cheng@tjh.tjmu.edu.cn
Contact: Yun Wang	+862783663333	820308045@qq.com

Locations

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China, Hubei
Bin Cheng
Wuhan, Hubei, China, 430030
Contact: Bin Cheng, Doctor 2783663333 b.cheng@tjh.tjmu.edu.cn
Contact: Yun Wang, Doctor +862783663333 820308045@qq.com
Principal Investigator: Bin Cheng, Doctor
Sub-Investigator: Yun Wang, Doctor

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

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Principal Investigator:	Bin Cheng	Tongji Hospital

More Information

Publications of Results:

DeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96.

Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.

Ge N, Zhang S, Jin Z, Sun S, Yang A, Wang B, Wang G, Xu G, Hao J, Zhong L, Zhong N, Li P, Zhu Q, Nian W, Li W, Zhang X, Zhou X, Yang X, Cui Y, Ding Z. Clinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17.

Gleeson FC, Kipp BR, Caudill JL, Clain JE, Clayton AC, Halling KC, Henry MR, Rajan E, Topazian MD, Wang KK, Wiersema MJ, Zhang J, Levy MJ. False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. Gut. 2010 May;59(5):586-93. doi: 10.1136/gut.2009.187765.

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.

Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.

Villa NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877.

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Responsible Party:	Bin Cheng, professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:	NCT03803930
Other Study ID Numbers:	FNB20
First Posted:	January 15, 2019 Key Record Dates
Last Update Posted:	January 17, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Bin Cheng, Huazhong University of Science and Technology:


EUS-FNB slow pull modified wet suction technique

Additional relevant MeSH terms:

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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases

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