Clinical trial NCT04100941: Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Mass
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
name: The Affiliated Hospital Of Southwest Medical University
name: Wuhan Union Hospital, China
name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2019-09-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: diagnostic accuracy of each individual technique
timeFrame: 1 year
measure: diagnostic sensitivity of each individual technique
timeFrame: 1 year
measure: specificity of each individual technique
timeFrame: 1 year
Secondary outcomes:
measure: adverse event rate of each individual technique
timeFrame: 1 year
measure: adequacy of specimens obtained by each individual technique
timeFrame: 1 year
measure: cellularity
timeFrame: 1 year
measure: blood contamination
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhao-shen Li, M.D.,Ph.D.
role: STUDY_CHAIR
References: