Cancer, Infection, Inflammation, Lymphoma, Mass Lesion, Neoplasms, Sarcoid
Conditions
Keywords
EUS-FNA
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.
Interventions
PROCEDUREStandard suction, slow-pull, wet suction
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.
PROCEDUREStandard suction, wet suction, slow-pull
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.
PROCEDURESlow-pull, standard suction, wet suction
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.
PROCEDURESlow-pull, wet suction, standard suction
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.
PROCEDUREWet suction, standard suction, slow-pull
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.
PROCEDUREWet suction, slow-pull, standard suction
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of wet suction technique | 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. |
| Diagnostic yield of standard suction technique | 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. |
| Diagnostic yield of slow-pull technique | 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 | 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. |
| Specimen quality score of standard suction | 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. |
| Specimen quality score of slow-pull | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 1 week | Including bleeding, infection, pneumonia, perforation and other procedure related adverse events. |
Countries
China
Contacts
Primary ContactTianyin Chen, M.D.
Outcome results
None listed