Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass

National Cheng-Kung University

Status: Unknown

Conditions: Endoscopic Ultrasonography; EUS-FNA; Pancreatic Neoplasms

Treatments: Procedure: EUS fine needle biopsy with heparin wet suction

Study type: Interventional

Funder types: Other

Identifiers

NCT04707560

NationalCheng-KungU

Details and patient eligibility

About

The objective of this randomized cross-over trial is to evaluate whether Heparin based wet suction technique, compared with dry suction technique, shall present a higher quality tissue core by using quantitative macroscopic and microscopic scale.

Full description

Background & aim Endoscopic ultrasound guided fine needle biopsy (EUS-FNB) is the main tool for tissue acquisition and pathological diagnosis of pancreatic solid mass because of its superior accuracy and lower complication rate compared to CT-guided biopsy. However, the tissue adequacy and diagnostic yield remained unsatisfactory for 2 reasons. First, the conventional dry suction technique (DST) often get small tissue and 3 or more needle passes (i.e. biopsies) are required to obtain enough specimen. Second, blood contamination of the acquired tissue interfered with microscopic examination. Investigator aim to develop a novel technique to improve tissue acquisition within a fewer needle passes and avoid blood contamination by using heparin-based modified wet suction (H-MWST).

Methods This study will be a randomized crossover clinical trial. Patients with pancreatic solid mass indicated for EUS FNB will be enrolled. EUS FNB will be done by one experienced endoscopists in National Cheng Kung University Hospital. Patients will be randomized in a 1:1 ratio to receive EUS FNB with either dry suction technique (DST) or H-MWST first for the initial 2 needle passes, and then crossover to another suction technique for a total of 4 needle passes. The obtained tissue of each needle pass will be sent separately and examined by a pathologist who is unaware of the procedure order. Procedure related complications will be recorded. The primary outcome will be the acquired tissue quality quantified comparison. The secondary outcome will be the overall diagnostic yield, the specimen adequacy, and complication rate by each suction technique.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients had pancreatic solid mass on CT scan or abdominal echo image

Exclusion criteria

• Anti-platelet and anticoagulant user who cannot stop the medication
• Recent acute pancreatitis episode (within 2 weeks)
• Patient with severe cardio-pulmonary dysfunction
• Pregnant women and adolescent < 20 years old

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Heparin Wet first group

Experimental group

Description:

Heparin based wet suction method of EUS FNB will go first for 2 passes and then shift to dry suction method for another 2 passes.

Treatment:

Procedure: EUS fine needle biopsy with heparin wet suction

Dry suction first group

Experimental group

Description:

Dry suction method of EUS FNB will go first for 2 passes and then shift to heparin base wet suction method for another 2 passes.

Treatment:

Procedure: EUS fine needle biopsy with heparin wet suction