Pancreatic Solid LesionsNCT03821974
The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions
A study testing wet suction technique and dry suction technique in people with Pancreatic Solid Lesions, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The objective of this randomized controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Solid Lesions
- What is being tested?
- wet suction technique and dry suction technique
- 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 siteChina
- Study dates
- 3 Jan 2019to 31 Mar 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years, < 80 years
- female or male
- Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI, CT, or ultrasonography) which identify that the pancreatic lesions are existing and solid.
- Agree to attend this study and signed informed consent letter
Who cannot join
- bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory dysfunction, and so on
- Coagulopathy (platelet count < 50,000/mm3, international normalized ratio > 1.5) or having taken oral anticoagulation agents such as aspirin or warfarin in the previous week
- Be rejected by anesthesia
- Acute pancreatitis in the previous 2 weeks
- Pregnant or lactation period
- Psychiatric disease, drug addiction, or other reason for unreliable follow-up or questionnaires
- Don't agree to attend this study and absence of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
The third Xiangya Hospital of central south University
Changsha, Hunan, 410003
About this study
Official title: The Comparison of Wet Suction Technique and Dry Suction Technique in Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) for the Outcomes in Pancreatic Solid Lesions: a Prospective, Randomized Controlled, Blinded Trial
The objective of this randomized controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics.
Read the detailed description
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable indispensable method for acquiring a pathological diagnosis in a variety of clinical conditions. It has been widely used due to the high sensitivity, specificity and safety. In order to improve the puncture efficiency of FNA, many domestic and oversea scholars have conducted several clinical trials. Among them, there are many studies on the type of needle, needle pattern, slow pull or vacuum suction, and there are only two related reports on wet suction (saline) and dry suction technique. There still have many controversies in the researchers about which technique is more dominant in the wet or dry suction. The wet suction technique is relying on pre-flushing the needle with saline to replace the column of air with fluid followed by aspiration at the proximal end, using a prefilled suction syringe with saline. It has been suggested that the presence of a saline-solution column might keep the needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so that it can improve the quality of specimens, diminish the contamination of blood, and increase the diagnostic yield and accuracy. Wet suction may become the development trend of EUS-FNA in the future because the application of wet suction is expected to improve the diagnostic efficiency and the quality of samples in FNA.
- Conditions
- Pancreatic Solid Lesions
- Being tested
- wet suction technique, dry suction technique
- Keywords
- Pancreatic solid lesions, wet suction technique, dry suction technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet suction techniqueProcedure or surgery
For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.
dry suction techniqueProcedure or surgery
For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.
| Study group | Role | What they receive |
|---|---|---|
| dry group | Experimental | The sequence of the technique of the puncture is dry-wet-dry-wet. Receives: Procedure: wet suction technique; Procedure: dry suction technique |
| wet group | Experimental | The sequence of the technique of the puncture is wet-dry-wet-dry. Receives: Procedure: wet suction technique; Procedure: dry suction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
Measured: 20 weeks
Secondary outcomes (4)
The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
Measured: 20 weeks
The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.
The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.
Measured: 20 weeks
The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.
The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.
Measured: 20 weeks
The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.
The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start3 Jan 2019
- Primary completion30 Sep 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Solid LesionsStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Tian, MD, Principal investigator, The Third Xiangya Hospital of Central South UniversityTing Tong, MD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821974
- Sponsor's protocol ID
- EUS2019-001
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2019
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Wet Suction Technique and Dry Suction Technique in Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) for the Outcomes in Pancreatic Solid Lesions: a Prospective, Randomized Controlled, Blinded Trial
- ClinicalTrials.gov ID
- NCT03821974
- Acronym / sponsor ID
- EUS2019-001
- Conditions
- Pancreatic Solid Lesions
- Keywords
- Pancreatic solid lesions, wet suction technique, dry suction technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 30 Jan 2019 (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 controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics.
Detailed description
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable indispensable method for acquiring a pathological diagnosis in a variety of clinical conditions. It has been widely used due to the high sensitivity, specificity and safety. In order to improve the puncture efficiency of FNA, many domestic and oversea scholars have conducted several clinical trials. Among them, there are many studies on the type of needle, needle pattern, slow pull or vacuum suction, and there are only two related reports on wet suction (saline) and dry suction technique. There still have many controversies in the researchers about which technique is more dominant in the wet or dry suction. The wet suction technique is relying on pre-flushing the needle with saline to replace the column of air with fluid followed by aspiration at the proximal end, using a prefilled suction syringe with saline. It has been suggested that the presence of a saline-solution column might keep the needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so that it can improve the quality of specimens, diminish the contamination of blood, and increase the diagnostic yield and accuracy. Wet suction may become the development trend of EUS-FNA in the future because the application of wet suction is expected to improve the diagnostic efficiency and the quality of samples in FNA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry group | Experimental | Procedure: wet suction technique, Procedure: dry suction techniqueThe sequence of the technique of the puncture is dry-wet-dry-wet. |
| wet group | Experimental | Procedure: wet suction technique, Procedure: dry suction techniqueThe sequence of the technique of the puncture is wet-dry-wet-dry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years, < 80 years
- female or male
- Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI, CT, or ultrasonography) which identify that the pancreatic lesions are existing and solid.
- Agree to attend this study and signed informed consent letter
Key exclusion criteria (7 listed)
- bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory dysfunction, and so on
- Coagulopathy (platelet count < 50,000/mm3, international normalized ratio > 1.5) or having taken oral anticoagulation agents such as aspirin or warfarin in the previous week
- Be rejected by anesthesia
- Acute pancreatitis in the previous 2 weeks
- Pregnant or lactation period
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 |
|---|---|---|
| wet suction techniqueFor the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion. | Procedure or surgery | dry group, wet group |
| dry suction techniqueFor the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion. | Procedure or surgery | dry group, wet group |
Primary outcome
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
Time frame: 20 weeks
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
4 secondary outcomes
The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
Time frame: 20 weeks
The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.
Time frame: 20 weeks
The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.
Time frame: 20 weeks
The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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EUS-DFI in Solid Pancreatic Lesions
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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.
Li Tian, MD principal investigator
The Third Xiangya Hospital of Central South University
Ting Tong, MD principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wet suction technique and dry suction technique in people with Pancreatic Solid Lesions, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jun 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique. (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2021.