Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions

Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial

Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Pancreatic Lesions; EUS-FNB
• Intervention / Treatment: Procedure: Dry suction; Procedure: Wet suction

Detailed Description

The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Yue, Doctor; Phone Number: +86 15975537291; Email: liyue_1989919@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age from 18 to 75 years;
• Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
• Plan to receive EUS-FNB.
• Able to obtained informed consent.

Exclusion Criteria:

• Had expected difficulty of endoscope insertion
• That no lesion in the pancreas is identified by EUS
• Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
• Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time >1.5 or a platelet count <50,000 cells/mL
• Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
• Vulnerable groups such as pregnant women or patients with mental disorders;
• Patients unable to understand and/or read the consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry suction group; 22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air)	Procedure: Dry suction; The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.
Active Comparator: Wet suction group; 22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry)	Procedure: Wet suction; The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy	compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Samples tissue integrity	The tissue integrity on histological analysis was graded into 3 levels: Grade A, existing core tissue (defined as an architecturally intact piece of tissue with a long axis measuring at least 550 μm), which can clearlycharacterize the lesion, and is sufficient for diagnosis; Grade B, existing core fragments, which does not meet the criteria for architecturally intact histology, but can still yield a diagnosis based on cell morphology;and Grade C, no lesion tissue found, and a diagnosis cannot be made based on the sample.	12 months
Samples cellularity	The cellularity of the cytological specimens was graded into 3 levels as follows : Grade A, more than 4 clusters, with a minimum of 10 cells in each cluster; Grade B, approximately 2-4 clusters, with a minimum of 10 cells in each cluster; and Grade C, fewer than 2 clusters or no cellular smear.	12 months
the diagnostic in relation to the number of needle passes	the diagnostic accuracy of each needle	12 months
Time (minutes) of the procedures with dry suction and wet suction	Time of the procedure is defined by the time from flushing the needle with saline solution to the removal of the needle after the last pass.	12 months
Percentage of procedure related adverse events [Safety]	Intra-procedural and post-procedural adverse events in the 2 arms will be evaluated	24 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Shenzhen People's Hospital; Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Li Yue, Doctor, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2022-335

Drug and device information, study documents

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