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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Endoscopic Ultrasonography EUS-FNA Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Heparin Wet first group

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.

Group Type EXPERIMENTAL

EUS fine needle biopsy with heparin wet suction

Intervention Type PROCEDURE

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.

Dry suction first group

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.

Group Type EXPERIMENTAL

EUS fine needle biopsy with heparin wet suction

Intervention Type PROCEDURE

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.

Interventions

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EUS fine needle biopsy with heparin wet suction

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.

Intervention Type PROCEDURE

Other Intervention Names

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EUS fine needle biopsy with dry suction

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No