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

Pancreatic Mass Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100941
• Other study ID #: EUS-FNB 25G
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2019
• Source: Changhai Hospital
• Contact: Wei Zhou, M.D.
• Phone: +8618021009362
• Email: zhou_wei0012[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Mass

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Changhai Hospital	Shenzhen People's Hospital, The Affiliated Hospital Of Southwest Medical University, The Second Affiliated Hospital of Harbin Medical University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy of each individual technique	The results are compared with the gold standard and calculated the accuracy	1 year
Primary	diagnostic sensitivity of each individual technique	The results are compared with the gold standard and calculated the sensitivity	1 year
Primary	specificity of each individual technique	The results are compared with the gold standard and calculated the specificity	1 year
Secondary	adverse event rate of each individual technique	record any adverse events related to the procedure	1 year
Secondary	adequacy of specimens obtained by each individual technique	the adequacy will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used	1 year
Secondary	cellularity	the cellularity will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used	1 year
Secondary	blood contamination	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	1 year