Comparing the Diagnostic Efficacy of Different Suction Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy of Pancreatic Solid Lesions Using 25G Procore Needle: a Prospective Randomized Controlled Multicentric Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Mass
- Sponsor
- Changhai Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- specificity of each individual technique
- Last Updated
- 6 years ago
Overview
Brief Summary
There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.
Detailed Description
the standard suction: after the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured. slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward. wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
Investigators
Zhaoshen Li
chief of the Gastroenterology
Changhai Hospital
Eligibility Criteria
Inclusion Criteria
- •age 18-75 years,male or female
- •diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- •lesion diameter larger than 1 cm
- •signed informed consent letter
Exclusion Criteria
- •pregnant female
- •Pancreatic cystic lesions
- •Anticoagulant/antiplatelet therapy cannot be suspended
- •unable or refuse to provide informed consent
- •Coagulopathy (platelet count \< 50× 103/μL,international normalized ratio \> 1.5)
- •Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- •with history of mental disease
- •other medical conditions that are not suitable for EUS-FNB
Outcomes
Primary Outcomes
specificity of each individual technique
Time Frame: 1 year
The results are compared with the gold standard and calculated the specificity
diagnostic accuracy of each individual technique
Time Frame: 1 year
The results are compared with the gold standard and calculated the accuracy
diagnostic sensitivity of each individual technique
Time Frame: 1 year
The results are compared with the gold standard and calculated the sensitivity
Secondary Outcomes
- cellularity(1 year)
- blood contamination(1 year)
- adverse event rate of each individual technique(1 year)
- adequacy of specimens obtained by each individual technique(1 year)