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Prospective randomized study comparing torque by twisting the scope and standard technique for EUS-guided tissue acquisition using core biopsy needles in solid pancreatic masses

Status Approved

  • First Submitted Date

    2017/05/11

  • Registered Date

    2017/05/24

  • Last Updated Date

    2018/08/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002338
    Unique Protocol ID 2017-020-I
    Public/Brief Title torque technique for EUS-guided FNB in solid pancreatic masses
    Scientific Title Prospective randomized study comparing torque by twisting the scope and standard technique for EUS-guided tissue acquisition using core biopsy needles in solid pancreatic masses
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2017-020-I
    Approval Date 2017-02-15
    Institutional Review Board Name Dongtan Sacred heart hospital Institutional Review Board/Ethics Committee
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Se Woo Park
    Title Prof.
    Telephone +82-31-8086-2858
    Affiliation Hallym University Medical Center-Dongtan
    Address 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea
    Contact Person for Public Queries
    Name Se Woo Park
    Title Prof.
    Telephone +82-31-8086-2858
    Affiliation Hallym University Medical Center-Dongtan
    Address 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea
    Contact Person for Updating Information
    Name Se Woo Park
    Title Prof.
    Telephone +82-31-8086-2858
    Affiliation Hallym University Medical Center-Dongtan
    Address 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do, 18450, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2017-04-25 Actual
    Target Number of Participant 118
    Primary Completion Date 2018-01-31 , Anticipated
    Study Completion Date 2018-03-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center-Dongtan
    Recruitment Status Recruiting
    Date of First Enrollment 2017-04-25 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Asan Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2017-05-08 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hallym University Medical Center-Dongtan
    Organization Type Medical Institute
    Project ID 2017-020-I
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University Medical Center-Dongtan
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Although the several techniques for improved outcomes in EUS-guided tissue acquisition are reported, the reported diagnostic yield for pancreatic solid tumors to date is not satisfactory. Among these technique, fanning method is well known superior to the standard approach in clinical practice. Instead of this, the effects of torque technique by twisting of scope to clock-wise or counter clock-wise direction during EUS-guided tissue acquisition of pancreatic mass lesions is not known. This study compared diagnostic yield obtained from EUS-guided tissue acquisition of pancreatic masses using torque technique and standard technique. 
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    Torque technique
    During each needle passage, the needle can be firstly advanced into the counterclockwise margin within the lesion under ultrasound guidance. And then, the endosonographer tried to make repetitive back-and-forth thrusting movements at the same time as twisting the body of the echoendoscope to the right (clockwise) with the lesion without using the left/right control knob. For individual needle passage, 10 uniform back-and-forth movements were performed within the lesion. The number of needle passages had been decided upon as only three times and was maintained constant based on previous noted reportsand our experience.
    
    Standard technique
    After puncture, the needle was repeatedly moved back and forth within the lesion 10 times with a thrusting and pulling force to scrape off the histologic tissue. The endosonographer paid more attention to pushing the needle sharply in to shear off tissue and pulling back slowly so that they enter the needle. Once a passage has been completed, deactivate suction and withdraw the needle completely into the sheath. And then, endosonographer repeat all the procedure from needle puncture to withdrawal, 3 times. In subsequent passes, a different margin of the mass was targeted but the needle movement was confined to the same area.
    Number of Arms 2
    Arm 1

    Arm Label

    Torque technique group

    Target Number of Participant

    59

    Arm Type

    Experimental

    Arm Description

    During each needle passage, the needle can be firstly advanced into the counterclockwise margin within the lesion under ultrasound guidance. And then, the endosonographer tried to make repetitive back-and-forth thrusting movements at the same time as twisting the body of the echoendoscope to the right (clockwise) with the lesion without using the left/right control knob. For individual needle passage, 10 uniform back-and-forth movements were performed within the lesion. The number of needle passages had been decided upon as only three times and was maintained constant based on previous noted reports and our experience.
    Arm 2

    Arm Label

    Standard technique group

    Target Number of Participant

    59

    Arm Type

    Active comparator

    Arm Description

    Standard technique
    After puncture, the needle was repeatedly moved back and forth within the lesion 10 times with a thrusting and pulling force to scrape off the histologic tissue. The endosonographer paid more attention to pushing the needle sharply in to shear off tissue and pulling back slowly so that they enter the needle. Once a passage has been completed, deactivate suction and withdraw the needle completely into the sheath. And then, endosonographer repeat all the procedure from needle puncture to withdrawal, 3 times. In subsequent passes, a different margin of the mass was targeted but the needle movement was confined to the same area.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K86.2)Cyst of pancreas 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    No Limit~No Limit

    Description

    Patients were eligible for the study based on the following criteria: suspected solid pancreatic masses based on clinical work up and image modality that required cytopathological confirmation. 
    Exclusion Criteria
    Exclusion criteria included: 
    (a) cystic pancreatic lesions without the evidence of solid component suspected with malignant transformation; 
    (b) cardiopulmonary instability; 
    (c) severe coagulopathy (international normalized ratio > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]); 
    (d) inability to suspend antithrombotic therapy; 
    (e) pregnancy;
    (f) refusal to provide informed consent or participate in the study. 
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    the procurement rates of histologic cores that the cyto-pathologist considered to be of optimal quality for histological evaluation of the needle gauge used for the EUS-FNB procedure
    Timepoint
    1-2 weeks after interventional EUS (after confirmation of final pathologic report)
    Secondary Outcome(s) 1
    Outcome
    diagnostic performance: diagnostic accuracy, sensitivity, specificity, PPV, NPV
    Timepoint
    1-2 weeks after interventional EUS (after confirmation of final pathologic report)
    Secondary Outcome(s) 2
    Outcome
    Technical failure
    Timepoint
    1-2 weeks after interventional EUS (after confirmation of final pathologic report)
    Secondary Outcome(s) 3
    Outcome
    Procedure related adverse events
    Timepoint
    1-2 weeks after interventional EUS (after confirmation of final pathologic report)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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