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

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

Conditions: EUS-FNB; Solid Pancreatic Lesions

Treatments: Procedure: Wet suction; Procedure: Dry suction

Study type: Interventional

Funder types: Other

Identifiers

NCT05549856

NFEC-2022-335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Dry suction group

Experimental group

Description:

22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air)

Treatment:

Procedure: Dry suction

Wet suction group

Active Comparator group

Description:

22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry)

Treatment:

Procedure: Wet suction