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

Not Applicable

Not yet recruiting

• Conditions: Solid Pancreatic Lesions; EUS-FNB
• Interventions: Procedure: Wet suction; Procedure: Dry suction

• Registration Number: NCT05549856
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2022-09
• Study Start: 2022-09
• Study First Submitted: 2022-09-18
• Study First Submitted QC: 2022-09-18
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-23
• Primary Completion: 2023-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wet suction group	Wet suction	22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry)
Dry suction group	Dry suction	22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air)

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Samples cellularity	12 months	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.
Percentage of procedure related adverse events [Safety]	24 months	Intra-procedural and post-procedural adverse events in the 2 arms will be evaluated
Samples tissue integrity	12 months	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.
the diagnostic in relation to the number of needle passes	12 months	the diagnostic accuracy of each needle
Time (minutes) of the procedures with dry suction and wet suction	12 months	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.