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Pancreas NeoplasmsNCT03803930

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

A study testing Using 22G FNB, the first pass is SP, Using 22G FNB, the first pass is MWST and Using 20G FNB, the first pass is SP in people with Pancreas Neoplasms, run by Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pancreas Neoplasms
What is being tested?
Using 22G FNB, the first pass is SP, Using 22G FNB, the first pass is MWST and Using 20G FNB, the first pass is SP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,224 participants
Where
1 siteChina
Study dates
1 Mar 2019to 1 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bin Cheng contact

+862783663333

b.cheng@tjh.tjmu.edu.cn

Yun Wang contact

+862783663333

820308045@qq.com

China1 site

  • Bin Cheng

    Wuhan, Hubei, 430030

    Bin Cheng, Doctor, 2783663333, b.cheng@tjh.tjmu.edu.cn

    Yun Wang, Doctor, +862783663333, 820308045@qq.com

Other trials in China

About this study

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

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.

Read the 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.

Being tested
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
Keywords
EUS-FNB, slow pull, modified wet suction technique
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using 22G FNB, the first pass is SPDevice

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

  • Using 22G FNB, the first pass is MWSTDevice

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

  • Using 20G FNB, the first pass is SPDevice

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

  • Using 20G FNB, the first pass is MWSTDevice

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

Study groups in NCT03803930
Study groupRoleWhat they receive
Arm 22G+SPOtherUsing 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Receives: Device: Using 22G FNB, the first pass is SP
Arm 22G+MWSTOtherUsing 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Receives: Device: Using 22G FNB, the first pass is MWST
Arm 20G+SPOtherUsing 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
Receives: Device: Using 20G FNB, the first pass is SP
Arm 20G+MWSTOtherUsing 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
Receives: Device: Using 20G FNB, the first pass is MWST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 15 months

Secondary outcomes (1)

  1. 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.

    Measured: up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start1 Mar 2019 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03803930
Sponsor's protocol ID
FNB20
Status last verified
Jan 2019
First submitted
25 Dec 2018
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15855973

  • 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.

    PubMed 22658389

  • 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.

    PubMed 28440232

  • 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.

    PubMed 20427392

  • 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.

    PubMed 28733257

  • 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.

    PubMed 25733127

  • 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.

    PubMed 26879162

Questions about this trial

What is this clinical trial studying?

A study testing Using 22G FNB, the first pass is SP, Using 22G FNB, the first pass is MWST and Using 20G FNB, the first pass is SP in people with Pancreas Neoplasms, run by Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bin Cheng (+862783663333, b.cheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic yields (time frame: up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803930, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.

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