Pancreatic DiseasesNCT06994611
Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions
A study testing MOSE application and Conventional processing in people with Pancreatic Diseases, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. 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?
- MOSE application and Conventional processing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 26 Aug 2026
- 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
- (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- 18-80 years old (inclusive), male and female;
- patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
- written informed consent was obtained;
Who cannot join
- (Before the trial, participants could not be enrolled if they met any of the following requirements)
- 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
About this study
Official title: Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
Read more
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was < 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
- Conditions
- Pancreatic Diseases
- Being tested
- MOSE application, Conventional processing
- Keywords
- EUS-FNB, solid pancreatic lesion, sample processing, 22D Franseen Needle
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSE applicationProcedure or surgery
The length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was < 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin.
Conventional processingProcedure or surgery
Two needles were punctured and all tissue strips were placed into bottle A formalin.
| Study group | Role | What they receive |
|---|---|---|
| MOSE group | Experimental | Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation Receives: Procedure: MOSE application |
| Non-mose group | Active comparator | Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin. Receives: Procedure: Conventional processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Measured: 6 months
Secondary outcomes (3)
Median puncture number
In the MOSE group, if the MVC of the first needle sample was ≥10mm, an additional needle was inserted. If the MVC of the first stitch is < 10mm, continue to puncture until the total length of the MVC of the sample is ≥10mm. In the non-MOSE group, fixed puncture was performed with 2 needles.
Measured: 2 months
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
Puncture time
The puncture time of the MOSE group was defined as the beginning of puncture to the end of the confirmation of sufficient MOSE, and the puncture time of the non-MOSE group was defined as the beginning of puncture to the end of 2 stitches.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start25 Jun 2025 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Aug 2026 (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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 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
- NCT06994611
- Sponsor's protocol ID
- KTSB20250327028
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Prospective Multicenter Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06994611
- Acronym / sponsor ID
- KTSB20250327028
- Conditions
- Pancreatic Diseases
- Keywords
- EUS-FNB, solid pancreatic lesion, sample processing, 22D Franseen Needle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 29 May 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 trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was < 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOSE group | Experimental | Procedure: MOSE applicationPatients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation |
| Non-mose group | Active comparator | Procedure: Conventional processingPatients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
Key exclusion criteria (7 listed)
- (Before the trial, participants could not be enrolled if they met any of the following requirements)
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 |
|---|---|---|
| MOSE applicationThe length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was < 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin. | Procedure or surgery | MOSE group |
| Conventional processingTwo needles were punctured and all tissue strips were placed into bottle A formalin. | Procedure or surgery | Non-mose group |
Primary outcome
Diagnostic accuracy
Time frame: 6 months
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
3 secondary outcomes
Median puncture number
Time frame: 2 months
Tissue adequacy
Time frame: 2 months
Puncture time
Time frame: 2 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 6 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 MOSE application and Conventional processing 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 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: opening soon, as of the sponsor's last update on 6 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?
Diagnostic accuracy (time frame: 6 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 6 Jun 2025.