NCT02327065

Brief Summary

The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 11, 2014

Last Update Submit

December 29, 2014

Conditions

Pancreas NeoplasmsLymphatic MetastasisNeoplasm MetastasesUnknown Primary Neoplasm Metastasis

Keywords

EUSFNAFNB

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Yield on malignancy

    The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB

    18 months

Secondary Outcomes (1)

  • Blood contamination and cellularity in specimens obtained by EUS-FNA and EUS-FNB with Slow-pull or suction

    18 months

Study Arms (2)

EUS-FNA Group

ACTIVE COMPARATOR

FNA,Fine needle aspiration

Device: EUS-FNA (EchoTip Ultra)

EUS-FNB Group

ACTIVE COMPARATOR

FNB,Fine needle biopsy

Device: EUS-FNB (EchoTip ProCore)

Interventions

EUS-FNA (EchoTip Ultra)DEVICE

FNA,Fine needle aspiration

Also known as: EchoTip Ultra needle
EUS-FNA Group
EUS-FNB (EchoTip ProCore)DEVICE

FNB,Fine needle biopsy

Also known as: EchoTip ProCore needle
EUS-FNB Group

Eligibility Criteria

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

You may qualify if:

  • All patients referred for EUS tissue sampling who provide informed consent

You may not qualify if:

  • Coagulopathy which is not corrected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 15855973RESULT

  • Puli SR, Batapati Krishna Reddy J, Bechtold ML, Ibdah JA, Antillon D, Singh S, Olyaee M, Antillon MR. Endoscopic ultrasound: it's accuracy in evaluating mediastinal lymphadenopathy? A meta-analysis and systematic review. World J Gastroenterol. 2008 May 21;14(19):3028-37. doi: 10.3748/wjg.14.3028.

    PMID: 18494054RESULT

  • Puri R, Vilmann P, Sud R, Kumar M, Taneja S, Verma K, Kaushik N. Endoscopic ultrasound-guided fine-needle aspiration cytology in the evaluation of suspected tuberculosis in patients with isolated mediastinal lymphadenopathy. Endoscopy. 2010 Jun;42(6):462-7. doi: 10.1055/s-0029-1244133. Epub 2010 Apr 29.

    PMID: 20432206RESULT

  • Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.

    PMID: 9097990RESULT

  • Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.

    PMID: 9087830RESULT

  • Affolter KE, Schmidt RL, Matynia AP, Adler DG, Factor RE. Needle size has only a limited effect on outcomes in EUS-guided fine needle aspiration: a systematic review and meta-analysis. Dig Dis Sci. 2013 Apr;58(4):1026-34. doi: 10.1007/s10620-012-2439-2. Epub 2012 Oct 21.

    PMID: 23086117RESULT

  • Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.

    PMID: 21420083RESULT

  • 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: 23433878RESULT

  • Layfield LJ, Schmidt RL, Hirschowitz SL, Olson MT, Ali SZ, Dodd LL. Significance of the diagnostic categories "atypical" and "suspicious for malignancy" in the cytologic diagnosis of solid pancreatic masses. Diagn Cytopathol. 2014 Apr;42(4):292-6. doi: 10.1002/dc.23078. Epub 2014 Feb 28.

    PMID: 24578254RESULT

  • 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.

    PMID: 28733257DERIVED

  • Wang J, Wu X, Yin P, Guo Q, Hou W, Li Y, Wang Y, Cheng B. Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial. Trials. 2016 Apr 12;17:198. doi: 10.1186/s13063-016-1316-2.

    PMID: 27071386DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsLymphatic MetastasisNeoplasm MetastasisNeoplasms, Unknown Primary

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Bin Cheng, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng, Doctor

CONTACT

86-027-8366-3333bcheng@tjh.tjmu.edu.cn

Jinlin Wang, Doctor

CONTACT

86-027-8366-3333417661238@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 30, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

May 1, 2016

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

CN(1)