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

NCT ID: NCT03803930

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-08-01

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.

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.

Conditions

Pancreas Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Arm 22G+SP

Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.

Group Type: OTHER

Using 22G FNB, the first pass is SP

Intervention Type: DEVICE

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.

Group Type: OTHER

Using 22G FNB, the first pass is MWST

Intervention Type: DEVICE

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.

Group Type: OTHER

Using 20G FNB, the first pass is SP

Intervention Type: DEVICE

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.

Group Type: OTHER

Using 20G FNB, the first pass is MWST

Intervention Type: DEVICE

Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Bin Cheng

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bin Cheng

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Bin Cheng

Wuhan, Hubei, China

Countries

China

Central Contacts

Bin Cheng

Role: CONTACT

b.cheng@tjh.tjmu.edu.cn

+862783663333

Yun Wang

Role: CONTACT

820308045@qq.com

+862783663333

Facility Contacts

Bin Cheng, Doctor

Role: primary

b.cheng@tjh.tjmu.edu.cn

2783663333

Yun Wang, Doctor

Role: backup

820308045@qq.com

+862783663333

References

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Reference Type: RESULT

PMID: 15855973 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22658389 (View on PubMed)

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. No abstract available.

Reference Type: RESULT

PMID: 28440232 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20427392 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28733257 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25733127 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26879162 (View on PubMed)

Other Identifiers

FNB20

Identifier Type: -

Identifier Source: org_study_id