NCT04605042

Brief Summary

The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

October 1, 2020

Last Update Submit

November 25, 2020

Conditions

Pancreatic NeoplasmsDiagnoses Disease

Keywords

endoscopic ultrasoundendoscopic ultrasound guided FNB

Outcome Measures

Primary Outcomes (2)

  • diagnostic sensitivity of WS technique and SNP technique by EUS-FNB

    Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB

    6 month

  • diagnostic specificity of WS technique and SNP technique by EUS-FNB

    specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB

    6 month

Secondary Outcomes (2)

  • Sample adequacy of WS technique and SNP technique by EUS-FNB

    6 month

  • Cell density of WS technique and SNP technique by EUS-FNB

    6 month

Study Arms (2)

WET First group

EXPERIMENTAL

COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence

Procedure: wet suctionProcedure: standard negative pressure suction

STANDARD first group

EXPERIMENTAL

COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence

Procedure: wet suctionProcedure: standard negative pressure suction

Interventions

wet suctionPROCEDURE

Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe

STANDARD first groupWET First group
standard negative pressure suctionPROCEDURE

after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.

STANDARD first groupWET First group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • Subjects over 18 years old
  • Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm

You may not qualify if:

  • Unable or refused to sign informed consent
  • suspended anticoagulant/antiplatelet therapy
  • Being pregnant or breastfeeding
  • Cystic lesions of the pancreas
  • coagulation disorders (PLT \<50×103/ L, INR \> 1.5)
  • A history of mental illness
  • other medical conditions that are not suitable for FNB puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.

    PMID: 28511234BACKGROUND

  • Banafea O, Mghanga FP, Zhao J, Zhao R, Zhu L. Endoscopic ultrasonography with fine-needle aspiration for histological diagnosis of solid pancreatic masses: a meta-analysis of diagnostic accuracy studies. BMC Gastroenterol. 2016 Aug 31;16(1):108. doi: 10.1186/s12876-016-0519-z.

    PMID: 27580856BACKGROUND

  • Puli SR, Bechtold ML, Buxbaum JL, Eloubeidi MA. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass?: A meta-analysis and systematic review. Pancreas. 2013 Jan;42(1):20-6. doi: 10.1097/MPA.0b013e3182546e79.

    PMID: 23254913BACKGROUND

  • Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.

    PMID: 23433878BACKGROUND

  • Moller K, Papanikolaou IS, Toermer T, Delicha EM, Sarbia M, Schenck U, Koch M, Al-Abadi H, Meining A, Schmidt H, Schulz HJ, Wiedenmann B, Rosch T. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc. 2009 Jul;70(1):60-9. doi: 10.1016/j.gie.2008.10.008. Epub 2009 Apr 25.

    PMID: 19394012BACKGROUND

  • Sakamoto H, Kitano M, Komaki T, Noda K, Chikugo T, Dote K, Takeyama Y, Das K, Yamao K, Kudo M. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol. 2009 Mar;24(3):384-90. doi: 10.1111/j.1440-1746.2008.05636.x. Epub 2008 Nov 20.

    PMID: 19032453BACKGROUND

  • Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.

    PMID: 28898917BACKGROUND

  • Alatawi A, Beuvon F, Grabar S, Leblanc S, Chaussade S, Terris B, Barret M, Prat F. Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J. 2015 Aug;3(4):343-52. doi: 10.1177/2050640615577533.

    PMID: 26279842BACKGROUND

  • 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.

    PMID: 25733127BACKGROUND

  • Wang Y, Wang RH, Ding Z, Tan SY, Chen Q, Duan YQ, Zhu LR, Cao JW, Wang J, Shi G, Wu XL, Wang JL, Zhao YC, Tang SJ, Cheng B. Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial. Endoscopy. 2020 Nov;52(11):995-1003. doi: 10.1055/a-1167-2214. Epub 2020 May 15.

    PMID: 32413915BACKGROUND

  • Li DF, Wang JY, Yang MF, Xiong F, Zhang DG, Xu ZL, Luo MH, Jing ZD, Wang KX, Wang LS, Yao J. Factors associated with diagnostic accuracy, technical success and adverse events of endoscopic ultrasound-guided fine-needle biopsy: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2020 Aug;35(8):1264-1276. doi: 10.1111/jgh.14999. Epub 2020 Feb 23.

    PMID: 32003100BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • DuoWu Zou, Ph.D,M.D

    Ruijin hospital Shanghai Jiaotong Universtity, school of medicine

    STUDY CHAIR

Central Study Contacts

DuoWu Zou, Ph.D,M.D

CONTACT

+86 13901617608zdw_pi@163.com

Chunhua Zhou, Ph.D,M.D

CONTACT

+86 13616275889zhou_chunh@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. and director

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 27, 2020

Study Start

December 1, 2020

Primary Completion

June 1, 2022

Study Completion

September 30, 2022

Last Updated

November 27, 2020

Record last verified: 2020-11