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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Mass
• Intervention / Treatment: Diagnostic test: standard suction; Diagnostic test: slow pull; Diagnostic test: 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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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.
EXPERIMENTAL: 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	Diagnostic test: slow pull; After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
EXPERIMENTAL: 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	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy of each individual technique	The results are compared with the gold standard and calculated the accuracy	1 year
diagnostic sensitivity of each individual technique	The results are compared with the gold standard and calculated the sensitivity	1 year
specificity of each individual technique	The results are compared with the gold standard and calculated the specificity	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event rate of each individual technique	record any adverse events related to the procedure	1 year
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
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
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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shenzhen People's Hospital; Wuhan Union Hospital, China; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Hospital Of Southwest Medical University
• Investigators: Study Chair: Zhao-shen Li, M.D.,Ph.D., Changhai Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2019
• Primary Completion (ANTICIPATED): May 30, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (ACTUAL): September 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EUS-FNB 25G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No