Pancreatic Mass
Conditions
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.
Interventions
DIAGNOSTIC_TESTstandard 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.
DIAGNOSTIC_TESTslow pull
After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
DIAGNOSTIC_TESTwet 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.
Sponsors
Shenzhen People's Hospital
The Affiliated Hospital Of Southwest Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The Second Affiliated Hospital of Harbin Medical University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-75 years,male or female 2. diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI) 3. lesion diameter larger than 1 cm 4. signed informed consent letter
Exclusion criteria
1. pregnant female 2. Pancreatic cystic lesions 3. Anticoagulant/antiplatelet therapy cannot be suspended 4. unable or refuse to provide informed consent 5. Coagulopathy (platelet count \< 50× 103/μL,international normalized ratio \> 1.5) 6. Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia 7. with history of mental disease 8. other medical conditions that are not suitable for EUS-FNB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy of each individual technique | 1 year | The results are compared with the gold standard and calculated the accuracy |
| diagnostic sensitivity of each individual technique | 1 year | The results are compared with the gold standard and calculated the sensitivity |
| specificity of each individual technique | 1 year | The results are compared with the gold standard and calculated the specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse event rate of each individual technique | 1 year | record any adverse events related to the procedure |
| blood contamination | 1 year | the blood contamination will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used |
| adequacy of specimens obtained by each individual technique | 1 year | the adequacy will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used |
| cellularity | 1 year | the cellularity will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used |
Countries
China
Contacts
Primary ContactWei Zhou, M.D.
Outcome results
None listed