Heparin-based Wet Suction Method In EUS Fine Needle Biopsy Of Solid Pancreatic Mass

Study Overview

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

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.

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.

Endoscopic Ultrasonography
EUS-FNA
Pancreatic Neoplasms

PROCEDURE: EUS fine needle biopsy with heparin wet suction

NationalCheng-KungU

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-04-05
First Submitted that Met QC Criteria 2021-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-04-08
First Posted (ACTUAL) 2021-01-13	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	PROCEDURE: 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 inserti
EXPERIMENTAL: 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.	PROCEDURE: 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 inserti

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

PROCEDURE: 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 inserti

EXPERIMENTAL: 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.

PROCEDURE: 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 inserti

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: MengYing Lin, M.D.

Phone Number: 886-6-2353535

Email: mikepjy@hotmail.com

Study Contact Backup

Name: Wei Lun Chang, Ph.D.

Phone Number: 886-6-2353535

Email: changwl6@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Bor-Shyang Sheu, Professor, National Cheng-Kung University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Mok SRS, Diehl DL, Johal AS, Khara HS, Confer BD, Mudireddy PR, Kirchner HL, Chen ZE. A prospective pilot comparison of wet and dry heparinized suction for EUS-guided liver biopsy (with videos). Gastrointest Endosc. 2018 Dec;88(6):919-925. doi: 10.1016/j.gie.2018.07.036. Epub 2018 Aug 16.
Diehl DL, Mok SRS, Khara HS, Johal AS, Kirchner HL, Lin F. Heparin priming of EUS-FNA needles does not adversely affect tissue cytology or immunohistochemical staining. Endosc Int Open. 2018 Mar;6(3):E356-E362. doi: 10.1055/s-0043-121880. Epub 2018 Mar 7.
Kasugai H, Yamamoto R, Tatsuta M, Okano Y, Okuda S, Kishigami Y, Kitamura T, Wada A, Tamura H. Value of heparinized fine-needle aspiration biopsy in liver malignancy. AJR Am J Roentgenol. 1985 Feb;144(2):243-4. doi: 10.2214/ajr.144.2.243.
Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
Lin MY, Wu CL, Su YY, Huang CJ, Chang WL, Sheu BS. Tissue Quality Comparison Between Heparinized Wet Suction and Dry Suction in Endoscopic Ultrasound-Fine Needle Biopsy of Solid Pancreatic Masses: A Randomized Crossover Study. Gut Liver. 2023 Mar 15;17(2):318-327. doi: 10.5009/gnl220030. Epub 2022 Sep 2.

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