Pancreatic MassNCT04100941
Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions
A study testing standard suction, slow pull and wet suction in people with Pancreatic Mass, run by Changhai Hospital at 1 site in China.
Trial summary
There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Mass
- What is being tested?
- standard suction, slow pull and wet suction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2019to 30 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years,male or female
- diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- lesion diameter larger than 1 cm
- signed informed consent letter
Who cannot join
- pregnant female
- Pancreatic cystic lesions
- Anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
- Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- with history of mental disease
- other medical conditions that are not suitable for EUS-FNB
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
Zhaoshen Li, MD
About this study
Official title: Comparing the Diagnostic Efficacy of Different Suction Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy of Pancreatic Solid Lesions Using 25G Procore Needle: a Prospective Randomized Controlled Multicentric Clinical Study
There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.
Read the detailed description
the standard suction: after the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
- Conditions
- Pancreatic Mass
- Being tested
- standard suction, slow pull, wet suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard suctionDiagnostic test
After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow pullDiagnostic test
After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suctionDiagnostic test
After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
| Study group | Role | What they receive |
|---|---|---|
| standard suction | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure Receives: Diagnostic Test: standard suction |
| slow pull | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique Receives: Diagnostic Test: slow pull |
| wet suction | Experimental | This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique Receives: Diagnostic Test: wet suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of each individual technique
The results are compared with the gold standard and calculated the accuracy
Measured: 1 year
diagnostic sensitivity of each individual technique
The results are compared with the gold standard and calculated the sensitivity
Measured: 1 year
specificity of each individual technique
The results are compared with the gold standard and calculated the specificity
Measured: 1 year
Secondary outcomes (4)
adverse event rate of each individual technique
record any adverse events related to the procedure
Measured: 1 year
adequacy of specimens obtained by each individual technique
the adequacy will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used
Measured: 1 year
cellularity
the cellularity will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used
Measured: 1 year
blood contamination
the blood contamination will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start10 Jun 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic MassStudies 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
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital, The Affiliated Hospital Of Southwest Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao-shen Li, M.D.,Ph.D., Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100941
- Sponsor's protocol ID
- EUS-FNB 25G
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 24 Sep 2019
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Diagnostic Efficacy of Different Suction Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy of Pancreatic Solid Lesions Using 25G Procore Needle: a Prospective Randomized Controlled Multicentric Clinical Study
- ClinicalTrials.gov ID
- NCT04100941
- Acronym / sponsor ID
- EUS-FNB 25G
- Conditions
- Pancreatic Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shenzhen People's Hospital, The Affiliated Hospital Of Southwest Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 24 Sep 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.
There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.
Detailed description
the standard suction: after the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard suction | Experimental | Diagnostic Test: standard suctionThis arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure |
| slow pull | Experimental | Diagnostic Test: slow pullThis arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique |
| wet suction | Experimental | Diagnostic Test: wet suctionThis arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-75 years,male or female
- diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- lesion diameter larger than 1 cm
- signed informed consent letter
Key exclusion criteria (8 listed)
- pregnant female
- Pancreatic cystic lesions
- Anticoagulant/antiplatelet therapy cannot be suspended
- unable or refuse to provide informed consent
- Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
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 |
|---|---|---|
| standard suctionAfter the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured. | Diagnostic test | standard suction |
| slow pullAfter the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward. | Diagnostic test | slow pull |
| wet suctionAfter removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured. | Diagnostic test | wet suction |
Primary outcome
diagnostic accuracy of each individual technique
Time frame: 1 year
The results are compared with the gold standard and calculated the accuracy
diagnostic sensitivity of each individual technique
Time frame: 1 year
The results are compared with the gold standard and calculated the sensitivity
specificity of each individual technique
Time frame: 1 year
The results are compared with the gold standard and calculated the specificity
4 secondary outcomes
adverse event rate of each individual technique
Time frame: 1 year
adequacy of specimens obtained by each individual technique
Time frame: 1 year
cellularity
Time frame: 1 year
blood contamination
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Zhao-shen Li, M.D.,Ph.D. study chair
Changhai 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 standard suction, slow pull and wet suction in people with Pancreatic Mass, run by Changhai Hospital 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 8 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 24 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhou, M.D. (+8618021009362, zhou_wei0012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of each individual technique (time frame: 1 year). The study lists 3 primary outcomes in all. 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 24 Sep 2019; AzTrials last refreshed its copy on 31 Oct 2026.