Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 8, 2021
December 1, 2020
1.7 years
January 11, 2021
April 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Needle pass number needed to establish diagnosis
48 weeks
Diagnostic performance between different suction method
48 weeks
Other Outcomes (1)
Complication
54 weeks
Study Arms (2)
Heparin Wet first group
EXPERIMENTALHeparin 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 first group
EXPERIMENTALDry suction method of EUS FNB will go first for 2 passes and then shift to heparin base wet suction method for another 2 passes.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients had pancreatic solid mass on CT scan or abdominal echo image
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Related Publications (5)
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.
PMID: 30120956BACKGROUNDDiehl 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.
PMID: 29527558BACKGROUNDKasugai 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.
PMID: 2981458BACKGROUNDAttam 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.
PMID: 25733127BACKGROUNDLin 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.
PMID: 36052613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bor-Shyang Sheu, Professor
National Cheng-Kung University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
January 1, 2020
Primary Completion
September 30, 2021
Study Completion
December 31, 2021
Last Updated
April 8, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share