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Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions

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ClinicalTrials.gov Identifier: NCT02789371
Recruitment Status : Unknown
Verified June 2016 by Bin Cheng, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : June 3, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Bin Cheng, Huazhong University of Science and Technology

Brief Summary:
The purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasms Lymphatic Metastasis Neoplasm Metastases Unknown Primary Neoplasm Metastasis Infection Inflammation Sarcoid Lymphadenopathy Procedure: the first pass is made with 5ml suction technique Procedure: the first pass is made with modified wet suction technique Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparing of Modified Wet Suction Technique and Dry Suction Technique for Endoscopic Ultrasound -Guided Fine Needle Aspiration (EUS-FNA) of Solid Occupying Lesions: a Prospective Multi-center,Randomized,and Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm A
the first pass is made with 5ml suction technique
Procedure: the first pass is made with 5ml suction technique
the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.

Arm B
the first pass is made with modified wet suction technique
Procedure: the first pass is made with modified wet suction technique
the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.




Primary Outcome Measures :
  1. the overall diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the solid occupying lesions [ Time Frame: 18 months ]
    The investigators' primary outcome measure is to compare the overall diagnostic accuracy of modified wet suction technique and dry suction technique to the solid occupying lesions.


Secondary Outcome Measures :
  1. the diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the benign and malignant solid occupying pancreatic lesions and non-pancreatic lesions respectively. [ Time Frame: 18 months ]
    The investigators'secondary outcome measure is to compare the diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the benign and malignant solid occupying pancreatic lesions and non-pancreatic lesions respectively.

  2. Blood contamination and cellularity in specimens obtained by modified wet suction technique and 5ml dry suction technique [ Time Frame: 18 months ]
    The investigators'secondary outcome measure is to compare the cellularity and blood cell contamination of the solid occupying lesions with modified wet suction technique and 5ml dry suction technique.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years old,<80 years old;
  2. Gender: Male or Female;
  3. The patients who have solid occupying pancreatic lesions and non-pancreatic lesions (the diameter>1cm) within the range of imaging examination(MRI、CT、B-type ultrasonography) and ultrasonic endoscope examination and should conduct the biopsy to identify lesion nature;
  4. The patients who receive examinations in the research center;
  5. The patients who sign the informed consent.

Exclusion Criteria:

  1. Hemoglobin≤8.0 g/dl;
  2. Pregnant women;
  3. The patients who have coagulation disorders(PLT<50,000/mm3,INR>1.5,roughly calculation, INR>1.5, is equivalent to PT>18 seconds);
  4. The patients who took anticoagulants such as aspirin, warfarin in the latest week;
  5. The patients who suffered from acute pancreatitis in the past two weeks;
  6. The patients who have cardiopulmonary dysfunction, therefore cannot tolerate ultrasonic endoscope examination;
  7. The patients who cannot sign the informed consent(such as patients who have mental disease or drug addiction and so on).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789371


Contacts
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Contact: Bin Cheng, Doctor 86-027-8366-3334 bcheng@tjh.tjmu.edu.cn
Contact: Yun Wang, Doctor 86-027-8366-3334 820308045@qq.com

Locations
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China, Hubei
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Bin Cheng, Doctor    86-027-8366-3333    bcheng@tjh.tjmu.edu.cn   
Contact: Yun Wang, Doctor    86-027-8366-3333    820308045@qq.con   
Principal Investigator: Bin Cheng, Doctor         
Sub-Investigator: Yun Wang, Doctor         
Sponsors and Collaborators
Bin Cheng
Investigators
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Principal Investigator: Bin Cheng, Doctor Tongji Hospital
Principal Investigator: Yun Wang, Doctor Tongji Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bin Cheng, professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02789371     History of Changes
Other Study ID Numbers: S135
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bin Cheng, Huazhong University of Science and Technology:
EUS-FNA
modified wet suction technique
dry suction technique

Additional relevant MeSH terms:
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Neoplasms
Inflammation
Neoplasm Metastasis
Neoplasms, Second Primary
Lymphadenopathy
Pancreatic Neoplasms
Lymphatic Metastasis
Neoplasms, Unknown Primary
Pathologic Processes
Neoplastic Processes
Lymphatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases