Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques (EUS-FNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674710
Recruitment Status : Unknown
Verified September 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Diagnostic yield of standard suction technique [ Time Frame: 1 year ]
    A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
  • Diagnostic yield of slow-pull technique [ Time Frame: 1 year ]
    A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
  • Diagnostic yield of wet suction technique [ Time Frame: 1 year ]
    A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
  • Specimen quality score of standard suction [ Time Frame: Immediate ]
    EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/High power field(HPF), 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
  • Specimen quality score of slow-pull [ Time Frame: Immediate ]
    EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
  • Specimen quality score of wet suction [ Time Frame: Immediate ]
    EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Adverse event [ Time Frame: 1 week ]
Including bleeding, infection, pneumonia, perforation and other procedure related adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques
Official Title  ICMJE A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Suction Technique, Slow-pull Method and Wet Suction Technique on Specimen Quality and Diagnostic Accuracy in Endoscopic Ultrasound-guided Fine-needle Aspiration
Brief Summary The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neoplasms
  • Infection
  • Inflammation
  • Lymphoma
  • Cancer
  • Sarcoid
  • Mass Lesion
Intervention  ICMJE
  • Procedure: Standard suction, slow-pull, wet suction
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
  • Procedure: Standard suction, wet suction, slow-pull
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
  • Procedure: Slow-pull, standard suction, wet suction
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
  • Procedure: Slow-pull, wet suction, standard suction
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
  • Procedure: Wet suction, standard suction, slow-pull
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
  • Procedure: Wet suction, slow-pull, standard suction
    Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Study Arms  ICMJE
  • Experimental: Group A
    Patients assigned to group A will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Standard suction, slow-pull, wet suction
  • Experimental: Group B
    Patients assigned to group B will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Standard suction, wet suction, slow-pull
  • Experimental: Group C
    Patients assigned to group C will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Slow-pull, standard suction, wet suction
  • Experimental: Group D
    Patients assigned to group D will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Slow-pull, wet suction, standard suction
  • Experimental: Group E
    Patients assigned to group E will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Wet suction, standard suction, slow-pull
  • Experimental: Group F
    Patients assigned to group F will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
    Intervention: Procedure: Wet suction, slow-pull, standard suction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.

Exclusion Criteria:

  • Uncorrectable coagulopathy (INR > 1.5)
  • Uncorrectable thrombocytopenia (platelet < 50,000)
  • Cystic lesions
  • Inaccessible lesions to EUS
  • Contraindications for conscious sedation
  • Uncooperative patients
  • Refusal to consent form
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674710
Other Study ID Numbers  ICMJE B2017-195
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Zhongshan Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP