Endoscopic UltrasonographyNCT04707560
Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
A study testing EUS fine needle biopsy with heparin wet suction in people with Endoscopic Ultrasonography and EUS-FNA, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms
- What is being tested?
- EUS fine needle biopsy with heparin wet suction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had pancreatic solid mass on CT scan or abdominal echo image
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
MengYing Lin, 886-6-2353535 ext. 3283, mikepjy@hotmail.com
About this study
Official title: Comparison of Heparin-based Wet Suction Method With Dry 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.
Read the 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.
- Conditions
- Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms
- Being tested
- EUS fine needle biopsy with heparin wet suction
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS fine needle biopsy with heparin wet suctionProcedure or surgery
Also called EUS fine needle biopsy with dry 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.
| Study group | Role | What they receive |
|---|---|---|
| Heparin Wet first group | Experimental | 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. Receives: Procedure: EUS fine needle biopsy with heparin wet suction |
| Dry suction first group | Experimental | 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. Receives: Procedure: EUS fine needle biopsy with heparin wet suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (2)
Needle pass number needed to establish diagnosis
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
Measured: 48 weeks
Diagnostic performance between different suction method
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jan 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endoscopic UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bor-Shyang Sheu, Professor, Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707560
- Sponsor's protocol ID
- NationalCheng-KungU
- Status last verified
- Dec 2020
- First submitted
- 11 Jan 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30120956Diehl 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.
PubMed 29527558Kasugai 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.
PubMed 2981458Attam 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.
PubMed 25733127Lin 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.
PubMed 36052613
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
- ClinicalTrials.gov ID
- NCT04707560
- Acronym / sponsor ID
- NationalCheng-KungU
- Conditions
- Endoscopic Ultrasonography, EUS-FNA, Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin Wet first group | Experimental | Procedure: EUS fine needle biopsy with heparin wet suctionHeparin 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 | Experimental | Procedure: EUS fine needle biopsy with heparin wet suctionDry suction method of EUS FNB will go first for 2 passes and then shift to heparin base wet suction method for another 2 passes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients had pancreatic solid mass on CT scan or abdominal echo image
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS fine needle biopsy with heparin wet suctionAlso: EUS fine needle biopsy with dry suctionEUS 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. | Procedure or surgery | Dry suction first group, Heparin Wet first group |
Primary outcome
Quantification of tissue quality
Time frame: 48 weeks
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
2 secondary outcomes
Needle pass number needed to establish diagnosis
Time frame: 48 weeks
Diagnostic performance between different suction method
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 30120956Mok 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.
- Background: PubMed 29527558Diehl 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.
- Background: PubMed 2981458Kasugai 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.
- Background: PubMed 25733127Attam 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.
- Derived from this study: PubMed 36052613Lin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bor-Shyang Sheu, Professor study director
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS fine needle biopsy with heparin wet suction in people with Endoscopic Ultrasonography and EUS-FNA, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MengYing Lin, M.D. (886-6-2353535 ext. 3283, mikepjy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of tissue quality (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707560, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.