Pancreatic DiseasesNCT07023549
The 22G Franseen Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy
A study testing ABC, ACB and BAC in people with Pancreatic Diseases, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- ABC, ACB and BAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- （1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- （3）written informed consent was obtained.
Who cannot join
- contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
- bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
- confirmed pregnancy or possible pregnancy;
- pathological diagnosis has been obtained by other methods;
- refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days;
- other situations where EUS-FNB could not be performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kai Xuan Wang, M.D contact
China1 site
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Jia Yi Ma, M.D, +8613621819595, 504043536@qq.com
About this study
Official title: Comparing the Sample Quality of 22G Franseen Needle Combined With Different Aspiration Techniques in Endoscopic Ultrasound-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study
The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
Read the detailed description
Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Franseen needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy using a 22G Franseen needle.
- Conditions
- Pancreatic Diseases
- Being tested
- ABC, ACB, BAC, BCA, CAB
- Keywords
- 22G Franseen needle, solid pancreatic lesion, aspiration technique, Endoscopic ultrasound-guided fine-needle biopsy
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCProcedure or surgery
Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
ACBProcedure or surgery
Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
BACProcedure or surgery
Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
BCAProcedure or surgery
Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
CABProcedure or surgery
Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
CBAProcedure or surgery
Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.
| Study group | Role | What they receive |
|---|---|---|
| ABC group | Experimental | Not described Receives: Procedure: ABC |
| ACB group | Experimental | Not described Receives: Procedure: ACB |
| BAC group | Experimental | Not described Receives: Procedure: BAC |
| BCA group | Experimental | Not described Receives: Procedure: BCA |
| CAB group | Experimental | Not described Receives: Procedure: CAB |
| CBA group | Experimental | Not described Receives: Procedure: CBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue adequacy
Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
Measured: 2 months
Secondary outcomes (5)
Cellularity
Grade A: Satisfactory, with more than 4 clusters, each containing at least 10 cells for cytological analysis; Grade B: Adequate, with 2-4 clusters, each containing at least 10 cells for cytological analysis; Grade C: Insufficient, with<2 clusters suitable for cytological analysis or non-representative samples, or<50 cells with clear nuclear structures.
Measured: 2 months
Blood contamination
The histological blood contamination score is assessed by grading the percentage of red blood cells in the entire 40x magnified field of view. Grade A: Red blood cells are present in<25%of the slides; Grade B: Red blood cells occupy 25%-50%of the slide; Grade C: Red blood cells are present in>50%of the slides; Grade D: No tissue.
Measured: 2 months
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Measured: 6 months
Diagnostic sensitivity
Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.
Measured: 6 months
Diagnostic specificity
Diagnostic specificity was calculated as proportion of true negative in healthy cases.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao Shen Li, M.D, Principal investigator, Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023549
- Sponsor's protocol ID
- KTSB20250423034
- Status last verified
- May 2025
- First submitted
- 7 Jun 2025
- Last updated
- 17 Jun 2025
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Sample Quality of 22G Franseen Needle Combined With Different Aspiration Techniques in Endoscopic Ultrasound-Guided Fine-Needle Biopsy of Pancreatic Solid Lesions: A Randomized Controlled Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07023549
- Acronym / sponsor ID
- KTSB20250423034
- Conditions
- Pancreatic Diseases
- Keywords
- 22G Franseen needle, solid pancreatic lesion, aspiration technique, Endoscopic ultrasound-guided fine-needle biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jun 2025 (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 goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
Detailed description
Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Franseen needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy using a 22G Franseen needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ABC group | Experimental | Procedure: ABC |
| ACB group | Experimental | Procedure: ACB |
| BAC group | Experimental | Procedure: BAC |
| BCA group | Experimental | Procedure: BCA |
| CAB group | Experimental | Procedure: CAB |
| CBA group | Experimental | Procedure: CBA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- （1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- （3）written informed consent was obtained.
Key exclusion criteria (6 listed)
- contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
- bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
- confirmed pregnancy or possible pregnancy;
- pathological diagnosis has been obtained by other methods;
- refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days;
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 |
|---|---|---|
| ABCSuction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction. | Procedure or surgery | ABC group |
| ACBSuction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull. | Procedure or surgery | ACB group |
| BACSuction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction. | Procedure or surgery | BAC group |
| BCASuction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction. | Procedure or surgery | BCA group |
| CABSuction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull. | Procedure or surgery | CAB group |
| CBASuction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction. | Procedure or surgery | CBA group |
Primary outcome
Tissue adequacy
Time frame: 2 months
Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
5 secondary outcomes
Cellularity
Time frame: 2 months
Blood contamination
Time frame: 2 months
Diagnostic accuracy
Time frame: 6 months
Diagnostic sensitivity
Time frame: 6 months
Diagnostic specificity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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.
Kai Xuan Wang, M.D contact
Zhao Shen Li, M.D principal investigator
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABC, ACB and BAC in people with Pancreatic Diseases, 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Yi Ma, M.D (+8613621819595, 504043536@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue adequacy (time frame: 2 months). 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 Jun 2025.