NeoplasmsEUS-FNANCT03674710
A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques
A study testing Standard suction, slow-pull, wet suction, Standard suction, wet suction, slow-pull and Slow-pull, standard suction, wet suction in people with Neoplasms and Infection, run by Shanghai Zhongshan Hospital at 4 sites in China.
Trial summary
The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms, Infection, Inflammation
- What is being tested?
- Standard suction, slow-pull, wet suction, Standard suction, wet suction, slow-pull and Slow-pull, standard suction, wet suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 18 Dec 2017to 31 Dec 2019
- 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
- In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.
Who cannot join
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Cystic lesions
- Inaccessible lesions to EUS
- Contraindications for conscious sedation
- Uncooperative patients
- Refusal to consent form
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Limei Wang, M.D.
Ning Zhong, M.D.
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Tianyin Chen, M.D.
Yiqun Zhang, M.D.
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Sijie Hao, M.D.
Chen Jin, M.D.
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Ning Cui, M.D.
Jiwang Cao, M.D.
About this study
Official title: A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Suction Technique, Slow-pull Method and Wet Suction Technique on Specimen Quality and Diagnostic Accuracy in Endoscopic Ultrasound-guided Fine-needle Aspiration
The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.
- Being tested
- Standard suction, slow-pull, wet suction, Standard suction, wet suction, slow-pull, Slow-pull, standard suction, wet suction, Slow-pull, wet suction, standard suction, Wet suction, standard suction, slow-pull
- Keywords
- EUS-FNA
- Medical subject headings
- Neoplasms, Infections, Inflammation, Lymphoma, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard suction, slow-pull, wet suctionProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Standard suction, wet suction, slow-pullProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Slow-pull, standard suction, wet suctionProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Slow-pull, wet suction, standard suctionProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Wet suction, standard suction, slow-pullProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
Wet suction, slow-pull, standard suctionProcedure or surgery
Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients assigned to group A will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Standard suction, slow-pull, wet suction |
| Group B | Experimental | Patients assigned to group B will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Standard suction, wet suction, slow-pull |
| Group C | Experimental | Patients assigned to group C will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Slow-pull, standard suction, wet suction |
| Group D | Experimental | Patients assigned to group D will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Slow-pull, wet suction, standard suction |
| Group E | Experimental | Patients assigned to group E will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Wet suction, standard suction, slow-pull |
| Group F | Experimental | Patients assigned to group F will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. Receives: Procedure: Wet suction, slow-pull, standard suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of standard suction technique
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Measured: 1 year
Diagnostic yield of slow-pull technique
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Measured: 1 year
Diagnostic yield of wet suction technique
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Measured: 1 year
Specimen quality score of standard suction
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/High power field(HPF), 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Measured: Immediate
Specimen quality score of slow-pull
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Measured: Immediate
Specimen quality score of wet suction
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Measured: Immediate
Secondary outcomes (1)
Adverse event
Including bleeding, infection, pneumonia, perforation and other procedure related adverse events.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start18 Dec 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674710
- Sponsor's protocol ID
- B2017-195
- Acronym
- EUS-FNA
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 17 Sep 2018
- 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 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Suction Technique, Slow-pull Method and Wet Suction Technique on Specimen Quality and Diagnostic Accuracy in Endoscopic Ultrasound-guided Fine-needle Aspiration
- ClinicalTrials.gov ID
- NCT03674710
- Acronym / sponsor ID
- EUS-FNA / B2017-195
- Keywords
- EUS-FNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Sep 2018 (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 aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Standard suction, slow-pull, wet suctionPatients assigned to group A will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
| Group B | Experimental | Procedure: Standard suction, wet suction, slow-pullPatients assigned to group B will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
| Group C | Experimental | Procedure: Slow-pull, standard suction, wet suctionPatients assigned to group C will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
| Group D | Experimental | Procedure: Slow-pull, wet suction, standard suctionPatients assigned to group D will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
| Group E | Experimental | Procedure: Wet suction, standard suction, slow-pullPatients assigned to group E will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
| Group F | Experimental | Procedure: Wet suction, slow-pull, standard suctionPatients assigned to group F will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.
Key exclusion criteria (7 listed)
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Cystic lesions
- Inaccessible lesions to EUS
- Contraindications for conscious sedation
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 suction, slow-pull, wet suctionPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "slow-pull", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group A |
| Standard suction, wet suction, slow-pullPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "standard suction", "wet suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group B |
| Slow-pull, standard suction, wet suctionPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "standard suction", and "wet suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group C |
| Slow-pull, wet suction, standard suctionPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "slow-pull", "wet suction", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group D |
| Wet suction, standard suction, slow-pullPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "standard suction", and "slow-pull". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group E |
| Wet suction, slow-pull, standard suctionPatients will be sampled for a total of 3 consecutive FNA passes with a sequential method of "wet suction", "slow-pull", and "standard suction". After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence. | Procedure or surgery | Group F |
Primary outcome
Diagnostic yield of standard suction technique
Time frame: 1 year
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Diagnostic yield of slow-pull technique
Time frame: 1 year
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Diagnostic yield of wet suction technique
Time frame: 1 year
A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.
Specimen quality score of standard suction
Time frame: Immediate
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/High power field(HPF), 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Specimen quality score of slow-pull
Time frame: Immediate
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
Specimen quality score of wet suction
Time frame: Immediate
EUS-FNA obtained specimen is scored as follows: 1) blood contamination: 0 for severe, 1 for moderate, 2 for few; 2) tissue structure: 0 for none, 1 for 1-2 structures seen, 2 for more than 3 structures seen; 3) cell quantity: 0 for <10/HPF, 1 for <50/HPF, 2 for >50/HPF; 4) diagnosability: 0 for hard to diagnose, 1 for suspicious diagnose, 2 for definite diagnosis.
1 secondary outcome
Adverse event
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- 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.
4 sites 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, wet suction, Standard suction, wet suction, slow-pull and Slow-pull, standard suction, wet suction in people with Neoplasms and Infection, run by Shanghai Zhongshan Hospital at 4 sites 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 1 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: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Tianyin Chen, M.D. (+8613801635303, chen.tianyin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of standard suction technique (time frame: 1 year). The study lists 6 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 17 Sep 2018.