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

Primary Purpose

Pancreas Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Using 22G FNB, the first pass is SP
Using 22G FNB, the first pass is MWST
Using 20G FNB, the first pass is SP
Using 20G FNB, the first pass is MWST
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Neoplasms focused on measuring EUS-FNB, slow pull, modified wet suction technique

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bin Cheng

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Arm 22G+SP

Arm 22G+MWST

Arm 20G+SP

Arm 20G+MWST

Arm Description

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 and the pass sequence is MWST-SP-MWST-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 and the pass sequence is MWST-SP-MWST-SP.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2018
Last Updated
January 16, 2019
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03803930
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasms
Keywords
EUS-FNB, slow pull, modified wet suction technique

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 22G+SP
Arm Type
Other
Arm Description
Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm Title
Arm 22G+MWST
Arm Type
Other
Arm Description
Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Arm Title
Arm 20G+SP
Arm Type
Other
Arm Description
Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Arm Title
Arm 20G+MWST
Arm Type
Other
Arm Description
Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Intervention Type
Device
Intervention Name(s)
Using 22G FNB, the first pass is SP
Intervention Description
Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Intervention Type
Device
Intervention Name(s)
Using 22G FNB, the first pass is MWST
Intervention Description
Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Intervention Type
Device
Intervention Name(s)
Using 20G FNB, the first pass is SP
Intervention Description
Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Intervention Type
Device
Intervention Name(s)
Using 20G FNB, the first pass is MWST
Intervention Description
Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.
Primary Outcome Measure Information:
Title
The diagnostic yields
Description
The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.
Time Frame
up to 15 months
Secondary Outcome Measure Information:
Title
the tissue integrity
Description
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.
Time Frame
up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Cheng
Phone
+862783663333
Email
b.cheng@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Wang
Phone
+862783663333
Email
820308045@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Cheng
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bin Cheng
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Cheng, Doctor
Phone
2783663333
Email
b.cheng@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yun Wang, Doctor
Phone
+862783663333
Email
820308045@qq.com
First Name & Middle Initial & Last Name & Degree
Bin Cheng, Doctor
First Name & Middle Initial & Last Name & Degree
Yun Wang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15855973
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. doi: 10.1016/s0016-5107(05)00287-7.
Results Reference
result
PubMed Identifier
22658389
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/j.gie.2012.03.1392. Epub 2012 May 31.
Results Reference
result
PubMed Identifier
28440232
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 Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17. No abstract available.
Results Reference
result
PubMed Identifier
20427392
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):586-93. doi: 10.1136/gut.2009.187765.
Results Reference
result
PubMed Identifier
28733257
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.
Results Reference
result
PubMed Identifier
25733127
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.
Results Reference
result
PubMed Identifier
26879162
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.
Results Reference
result

Learn more about this trial

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

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