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The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions

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ClinicalTrials.gov Identifier: NCT03821974
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

Brief Summary:
The objective of this randomized controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics.

Condition or disease Intervention/treatment Phase
Pancreatic Solid Lesions Procedure: wet suction technique Procedure: dry suction technique Not Applicable

Detailed Description:
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable indispensable method for acquiring a pathological diagnosis in a variety of clinical conditions. It has been widely used due to the high sensitivity, specificity and safety. In order to improve the puncture efficiency of FNA, many domestic and oversea scholars have conducted several clinical trials. Among them, there are many studies on the type of needle, needle pattern, slow pull or vacuum suction, and there are only two related reports on wet suction (saline) and dry suction technique. There still have many controversies in the researchers about which technique is more dominant in the wet or dry suction. The wet suction technique is relying on pre-flushing the needle with saline to replace the column of air with fluid followed by aspiration at the proximal end, using a prefilled suction syringe with saline. It has been suggested that the presence of a saline-solution column might keep the needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so that it can improve the quality of specimens, diminish the contamination of blood, and increase the diagnostic yield and accuracy. Wet suction may become the development trend of EUS-FNA in the future because the application of wet suction is expected to improve the diagnostic efficiency and the quality of samples in FNA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Comparison of Wet Suction Technique and Dry Suction Technique in Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) for the Outcomes in Pancreatic Solid Lesions: a Prospective, Randomized Controlled, Blinded Trial
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: dry group
The sequence of the technique of the puncture is dry-wet-dry-wet.
Procedure: wet suction technique
For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.

Procedure: dry suction technique
For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.

Experimental: wet group
The sequence of the technique of the puncture is wet-dry-wet-dry.
Procedure: wet suction technique
For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.

Procedure: dry suction technique
For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.




Primary Outcome Measures :
  1. The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique. [ Time Frame: 20 weeks ]
    The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.


Secondary Outcome Measures :
  1. The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique. [ Time Frame: 20 weeks ]
    The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.

  2. The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique. [ Time Frame: 20 weeks ]
    The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.

  3. The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique. [ Time Frame: 20 weeks ]
    The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.

  4. The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique. [ Time Frame: 20 weeks ]
    The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration 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, < 80 years
  2. female or male
  3. Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI, CT, or ultrasonography) which identify that the pancreatic lesions are existing and solid.
  4. Agree to attend this study and signed informed consent letter

Exclusion Criteria:

  1. bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory dysfunction, and so on
  2. Coagulopathy (platelet count < 50,000/mm3, international normalized ratio > 1.5) or having taken oral anticoagulation agents such as aspirin or warfarin in the previous week
  3. Be rejected by anesthesia
  4. Acute pancreatitis in the previous 2 weeks
  5. Pregnant or lactation period
  6. Psychiatric disease, drug addiction, or other reason for unreliable follow-up or questionnaires
  7. Don't agree to attend this study and absence of informed consent

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): NCT03821974


Contacts
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Contact: Xiaoyan Wang, MD +8613974889301 wxy20011@163.com

Locations
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China, Hunan
The third Xiangya Hospital of central south University Recruiting
Changsha, Hunan, China, 410003
Contact: Xiaoyan Wang, MD         
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Li Tian, MD The Third Xiangya Hospital of Central South University
Principal Investigator: Ting Tong, MD The Third Xiangya Hospital of Central South University
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Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03821974    
Other Study ID Numbers: EUS2019-001
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Third Xiangya Hospital of Central South University:
Pancreatic solid lesions
wet suction technique
dry suction technique