Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions

Not Applicable

• Conditions: Pancreatic Mass

• Registration Number: NCT04100941
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2019-06-10
• Status Verified: 2019-09
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Last Update Submitted: 2019-09-23
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Primary Completion: 2020-05-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
specificity of each individual technique	1 year	The results are compared with the gold standard and calculated the specificity
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

Secondary Outcome Measures

Name	Time	Method
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
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
adverse event rate of each individual technique	1 year	record any adverse events related to the procedure
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

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China