EUS-FNB, Solid Pancreatic Lesions
Conditions
Brief summary
Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.
Detailed description
The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.
Interventions
PROCEDUREWet suction
The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.
PROCEDUREDry suction
The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 75 years; * Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis. * Plan to receive EUS-FNB. * Able to obtained informed consent.
Exclusion criteria
* Had expected difficulty of endoscope insertion * That no lesion in the pancreas is identified by EUS * Use of anticoagulants/antiplatelet drugs that cannot be discontinued. * Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time \>1.5 or a platelet count \<50,000 cells/mL * Other medical conditions that render the patient an unsuitable candidate for EUS-FNB. * Vulnerable groups such as pregnant women or patients with mental disorders; * Patients unable to understand and/or read the consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy | 12 months | compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Samples tissue integrity | 12 months | The tissue integrity on histological analysis was graded into 3 levels: Grade A, existing core tissue (defined as an architecturally intact piece of tissue with a long axis measuring at least 550 μm), which can clearlycharacterize the lesion, and is sufficient for diagnosis; Grade B, existing core fragments, which does not meet the criteria for architecturally intact histology, but can still yield a diagnosis based on cell morphology;and Grade C, no lesion tissue found, and a diagnosis cannot be made based on the sample. |
| Samples cellularity | 12 months | The cellularity of the cytological specimens was graded into 3 levels as follows : Grade A, more than 4 clusters, with a minimum of 10 cells in each cluster; Grade B, approximately 2-4 clusters, with a minimum of 10 cells in each cluster; and Grade C, fewer than 2 clusters or no cellular smear. |
| the diagnostic in relation to the number of needle passes | 12 months | the diagnostic accuracy of each needle |
| Time (minutes) of the procedures with dry suction and wet suction | 12 months | Time of the procedure is defined by the time from flushing the needle with saline solution to the removal of the needle after the last pass. |
| Percentage of procedure related adverse events [Safety] | 24 months | Intra-procedural and post-procedural adverse events in the 2 arms will be evaluated |
Contacts
Primary ContactLi Yue, Doctor
Outcome results
None listed