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

Not Applicable

• Conditions: Pancreatic Mass
• Interventions: Diagnostic Test: slow pull; Diagnostic Test: standard suction; Diagnostic Test: wet suction

• 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

Arm && Interventions

Group	Intervention	Description
slow pull	slow pull	This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
standard suction	standard suction	This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure
wet suction	wet suction	This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique

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