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

Pancreas Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03803930
• Other study ID #: FNB20
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2019
• Source: Huazhong University of Science and Technology
• Contact: Bin Cheng
• Phone: +862783663333
• Email: b.cheng[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1224
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age >18 years old,<85 years old;

2. Gender: Male or Female;

3. Presence solid occupying pancreatic lesions (the diameter>1cm);

4. Must be able to receive examinations in the research center;

5. Must be able to sign the informed consent.

Exclusion Criteria:

1. Hemoglobin=8.0 g/dl;

2. Pregnant women;

3. Coagulation disorders;

4. Took anticoagulants such as aspirin, warfarin in the latest week;

5. Acute pancreatitis in the past two weeks;

6. Cardiopulmonary dysfunction;

7. Cannot sign the informed consent

Related Conditions & MeSH terms

• Pancreas Neoplasms
• Pancreatic Neoplasms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Bin Cheng	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (7)

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, r — View Citation

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/ — View Citation

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 Controlle — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic yields	The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.	up to 15 months
Secondary	the tissue integrity	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.	up to 15 months