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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- Diagnostic yield of standard suction technique
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
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 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.
Secondary Outcomes
- Adverse event(1 week)