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

Primary Purpose

Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EUS fine needle biopsy with heparin wet suction
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endoscopic Ultrasonography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heparin Wet first group

Dry suction first group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Needle pass number needed to establish diagnosis
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
Diagnostic performance between different suction method
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result

Full Information

First Posted
January 11, 2021
Last Updated
April 5, 2021
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04707560
Brief Title
Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
Official Title
Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heparin Wet first group
Arm Type
Experimental
Arm 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.
Arm Title
Dry suction first group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
EUS fine needle biopsy with heparin wet suction
Other Intervention Name(s)
EUS fine needle biopsy with dry suction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantification of tissue quality
Description
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
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Needle pass number needed to establish diagnosis
Description
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
Time Frame
48 weeks
Title
Diagnostic performance between different suction method
Description
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Complication
Description
Investigator will keep follow up patient during admission course and 3 months after procedure to determine if presented with complications
Time Frame
54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MengYing Lin, M.D.
Phone
886-6-2353535
Ext
3283
Email
mikepjy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Lun Chang, Ph.D.
Phone
886-6-2353535
Ext
2681
Email
changwl6@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bor-Shyang Sheu, Professor
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MengYing Lin
Phone
886-6-2353535
Ext
3283
Email
mikepjy@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30120956
Citation
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.
Results Reference
background
PubMed Identifier
29527558
Citation
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.
Results Reference
background
PubMed Identifier
2981458
Citation
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.
Results Reference
background
PubMed Identifier
25733127
Citation
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.
Results Reference
background
PubMed Identifier
36052613
Citation
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.
Results Reference
derived

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

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