Clinical trial NCT03803930: Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Neoplasms
Keywords: EUS-FNB
slow pull
modified wet suction technique
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 1224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The diagnostic yields
timeFrame: up to 15 months
Secondary outcomes:
measure: the tissue integrity
timeFrame: up to 15 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Bin Cheng
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Bin Cheng
role: PRINCIPAL_INVESTIGATOR
References:
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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 Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19.
citation: 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.
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