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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neoplasms, Infection, Inflammation, Lymphoma, Cancer, Sarcoid, Mass Lesion

Intervention / Treatment
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* Procedure: Standard suction, slow-pull, wet suction
* Procedure: Standard suction, wet suction, slow-pull
* Procedure: Slow-pull, standard suction, wet suction
* Procedure: Slow-pull, wet suction, standard suction
* Procedure: Wet suction, standard suction, slow-pull
* Procedure: Wet suction, slow-pull, standard suction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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. | Procedure: Standard suction, slow-pull, wet suction<br>* 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.<br>|
| Experimental: Group B<br>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. | Procedure: Standard suction, wet suction, slow-pull<br>* 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.<br>|
| Experimental: Group C<br>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. | Procedure: Slow-pull, standard suction, wet suction<br>* 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.<br>|
| Experimental: Group D<br>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. | Procedure: Slow-pull, wet suction, standard suction<br>* 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.<br>|
| Experimental: Group E<br>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. | Procedure: Wet suction, standard suction, slow-pull<br>* 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.<br>|
| Experimental: Group F<br>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. | Procedure: Wet suction, slow-pull, standard suction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of standard suction technique | 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. | 1 year | 
| Diagnostic yield of slow-pull technique | 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. | 1 year | 
| Diagnostic yield of wet suction technique | 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. | 1 year | 
| Specimen quality score of standard suction | 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. | Immediate | 
| Specimen quality score of slow-pull | 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. | Immediate | 
| Specimen quality score of wet suction | 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. | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Including bleeding, infection, pneumonia, perforation and other procedure related adverse events. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-FNA