A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques
- Conditions
- NeoplasmsInfectionInflammationLymphomaCancerSarcoidMass Lesion
- Registration Number
- NCT03674710
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
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.
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 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.
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.
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 Outcome Measures
Name Time Method Adverse event 1 week Including bleeding, infection, pneumonia, perforation and other procedure related adverse events.
Trial Locations
- Locations (4)
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Renmin Hospital of Wuhan University🇨🇳Wuhan, Hubei, ChinaNing Cui, M.D.ContactJiwang Cao, M.D.Sub Investigator