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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass

Conditions
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Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: EUS fine needle biopsy with heparin wet suction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin Wet first group<br>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. | Procedure: EUS fine needle biopsy with heparin wet suction<br>* EUS FNB with Heparin wet suction: Investigator will remove stylet from the FNB device and then infuse Heparin 1ml (5000IU) into device before procedure. The syringe will pre-loaded with 10 ml negative pressure and attach to device upon needle tip insertion into mass lesion. EUS FNB with Dry suction: Investigator will remove stylet from the FNB device. Syringe will be pre-loaded with 10 ml negative pressure in syringe and attach to needle tail upon needle tip inserted into target lesion.<br>* Other names: EUS fine needle biopsy with dry suction;|
| Experimental: Dry suction first group<br>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. | Procedure: EUS fine needle biopsy with heparin wet suction<br>* EUS FNB with Heparin wet suction: Investigator will remove stylet from the FNB device and then infuse Heparin 1ml (5000IU) into device before procedure. The syringe will pre-loaded with 10 ml negative pressure and attach to device upon needle tip insertion into mass lesion. EUS FNB with Dry suction: Investigator will remove stylet from the FNB device. Syringe will be pre-loaded with 10 ml negative pressure in syringe and attach to needle tail upon needle tip inserted into target lesion.<br>* Other names: EUS fine needle biopsy with dry suction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of tissue quality | White tissue core length will be assessed immediately after procedure. The acquired tumor tissue area and contaminant blood clot percentage will be assessed after total recruitment by single pathologist | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle pass number needed to establish diagnosis | After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result | 48 weeks | 
| Diagnostic performance between different suction method | After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result | 48 weeks |