Solid Pancreatic LesionsNCT05549856
Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions
A study testing Wet suction and Dry suction in people with Solid Pancreatic Lesions and EUS-FNB, run by Nanfang Hospital, Southern Medical University.
Trial summary
Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Solid Pancreatic Lesions, EUS-FNB
- What is being tested?
- Wet suction and Dry suction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Feb 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years;
- Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
- Plan to receive EUS-FNB.
- Able to obtained informed consent.
Who cannot join
- Had expected difficulty of endoscope insertion
- That no lesion in the pancreas is identified by EUS
- Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
- Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time >1.5 or a platelet count <50,000 cells/mL
- Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
- Vulnerable groups such as pregnant women or patients with mental disorders;
- Patients unable to understand and/or read the consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.
Read the detailed description
The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.
- Conditions
- Solid Pancreatic Lesions, EUS-FNB
- Being tested
- Wet suction, Dry suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet suctionProcedure or surgery
The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.
Dry suctionProcedure or surgery
The pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique.
| Study group | Role | What they receive |
|---|---|---|
| Dry suction group | Experimental | 22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air) Receives: Procedure: Dry suction |
| Wet suction group | Active comparator | 22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry) Receives: Procedure: Wet suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions.
Measured: 12 months
Secondary outcomes (5)
Samples tissue integrity
The tissue integrity on histological analysis was graded into 3 levels: Grade A, existing core tissue (defined as an architecturally intact piece of tissue with a long axis measuring at least 550 μm), which can clearlycharacterize the lesion, and is sufficient for diagnosis; Grade B, existing core fragments, which does not meet the criteria for architecturally intact histology, but can still yield a diagnosis based on cell morphology;and Grade C, no lesion tissue found, and a diagnosis cannot be made based on the sample.
Measured: 12 months
Samples cellularity
The cellularity of the cytological specimens was graded into 3 levels as follows : Grade A, more than 4 clusters, with a minimum of 10 cells in each cluster; Grade B, approximately 2-4 clusters, with a minimum of 10 cells in each cluster; and Grade C, fewer than 2 clusters or no cellular smear.
Measured: 12 months
the diagnostic in relation to the number of needle passes
the diagnostic accuracy of each needle
Measured: 12 months
Time (minutes) of the procedures with dry suction and wet suction
Time of the procedure is defined by the time from flushing the needle with saline solution to the removal of the needle after the last pass.
Measured: 12 months
Percentage of procedure related adverse events [Safety]
Intra-procedural and post-procedural adverse events in the 2 arms will be evaluated
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Pancreatic LesionsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital
- Responsible party
- Sponsor
- Investigators
- Li Yue, Doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549856
- Sponsor's protocol ID
- NFEC-2022-335
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu S, Guo J, Qin M, Meng Y, Xie F, Qiao W, Hu H, Peng P, Rownoak J, Heng S, Ung F, Ye Y, Wang J, Li W, Zou Y, Zou L, Huang S, Liu S, Wang J, Yao J, Li Y. Dry Suction Versus Wet Suction of Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Multicenter Randomized Controlled Noninferiority Trial. Am J Gastroenterol. 2025 Nov 1;120(11):2529-2537. doi: 10.14309/ajg.0000000000003389. Epub 2025 Feb 27.
PubMed 40019152Xu S, Wang J, Guo J, Xie F, Qiao W, Meng Y, Peng P, Hu H, Huang Y, Liu S, Qin M, Yao J, Li Y. Dry suction versus wet suction technique of endoscopic ultrasound-guided fine-needle biopsy for diagnosis of solid pancreatic lesions: study protocol of a multicenter randomized controlled non-inferiority trial. Trials. 2023 Dec 13;24(1):805. doi: 10.1186/s13063-023-07842-8.
PubMed 38093381
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05549856
- Acronym / sponsor ID
- NFEC-2022-335
- Conditions
- Solid Pancreatic Lesions, EUS-FNB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Sep 2022 (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.
Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.
Detailed description
The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry suction group | Experimental | Procedure: Dry suction22G Franseen needle biopsy with dry suction technique(The puncture needle be filled with air) |
| Wet suction group | Active comparator | Procedure: Wet suction22G Franseen needle biopsy with wet suction(The puncture needle be filled with saline before sugry) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75 years;
- Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
- Plan to receive EUS-FNB.
- Able to obtained informed consent.
Key exclusion criteria (7 listed)
- Had expected difficulty of endoscope insertion
- That no lesion in the pancreas is identified by EUS
- Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
- Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time >1.5 or a platelet count <50,000 cells/mL
- Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
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 suctionThe pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). Before puncturing the lesion, flush the needle with 5ml saline, then use a 10 ml syringe in order to replacing the column of air with fluid. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique. | Procedure or surgery | Wet suction group |
| Dry suctionThe pancreatic solid lesions will be puncture with the 22G Acquire needle (Boston Scientific Corporation, Marlborough, MA, USA). The stylet is removed and a 10 ml air-filled pre-vacuum syringe is attached. After puncture, monitoring the puncture needle under US guidance in real time, the needle was moved back and forth about 10-20 times within the lesion using a fanning technique. | Procedure or surgery | Dry suction group |
Primary outcome
diagnostic accuracy
Time frame: 12 months
compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions.
5 secondary outcomes
Samples tissue integrity
Time frame: 12 months
Samples cellularity
Time frame: 12 months
the diagnostic in relation to the number of needle passes
Time frame: 12 months
Time (minutes) of the procedures with dry suction and wet suction
Time frame: 12 months
Percentage of procedure related adverse events [Safety]
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 40019152Xu S, Guo J, Qin M, Meng Y, Xie F, Qiao W, Hu H, Peng P, Rownoak J, Heng S, Ung F, Ye Y, Wang J, Li W, Zou Y, Zou L, Huang S, Liu S, Wang J, Yao J, Li Y. Dry Suction Versus Wet Suction of Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Multicenter Randomized Controlled Noninferiority Trial. Am J Gastroenterol. 2025 Nov 1;120(11):2529-2537. doi: 10.14309/ajg.0000000000003389. Epub 2025 Feb 27.
- Derived from this study: PubMed 38093381Xu S, Wang J, Guo J, Xie F, Qiao W, Meng Y, Peng P, Hu H, Huang Y, Liu S, Qin M, Yao J, Li Y. Dry suction versus wet suction technique of endoscopic ultrasound-guided fine-needle biopsy for diagnosis of solid pancreatic lesions: study protocol of a multicenter randomized controlled non-inferiority trial. Trials. 2023 Dec 13;24(1):805. doi: 10.1186/s13063-023-07842-8.
Related trials for Solid Pancreatic Lesions
Recruiting
Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) Malignancy
Pancreas Adenocarcinoma (MSI-H), Pancreatic Neuroendocrine Tumors (pNET)
Not yet recruitingObservational study
EUS-DFI in Solid Pancreatic Lesions
Pancreatic Neoplasms, Pancreatic Solid Lesions
RecruitingObservational study
An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound
Endoscopic Ultrasound (EUS), Solid Pancreatic Lesion
Not yet recruiting
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
Pancreatic Neoplasms, Mediastinal Neoplasms
Recruiting
RCT Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip EUS-FNB Needle in Diagnosis of Solid Pancreatic Lesions
Pancreatic Masses
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 Yue, Doctor principal investigator
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Wet suction and Dry suction in people with Solid Pancreatic Lesions and EUS-FNB, run by Nanfang Hospital, Southern Medical University.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Li Yue, Doctor (+86 15975537291, liyue_1989919@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 12 months). 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 NCT05549856, which also lists 2 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 23 Sep 2022.