Pancreatic NeoplasmsMORENCT03766659
EUS-FNB With MOSE vs EUS-FNA With ROSE
A study testing MOSE and ROSE in people with Pancreatic Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- MOSE and ROSE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Jun 2019to 1 Sep 2024
- 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
- Aged between 18 and 80 years
- Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter
Who cannot join
- Coagulopathy
- Altered anatomy
- Contraindications for conscious sedation
- Pregnancy
- Those who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery; The Chinese University of Hong Kong
Hong Kong
Charing C Chong, MBChB, 852-26321496, Chongcn@surgery.cuhk.edu.hk
Charing C Chong, MBChB
About this study
Official title: Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.
In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.
Read the detailed description
The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.
- Conditions
- Pancreatic Neoplasms
- Being tested
- MOSE, ROSE
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSEDiagnostic test
EUS-FNB with MOSE
ROSEDiagnostic test
EUS-FNA with ROSE
| Study group | Role | What they receive |
|---|---|---|
| MOSE | Other | EUS-FNB with MOSE Receives: Diagnostic Test: MOSE |
| ROSE | Other | EUS-FNA with ROSE Receives: Diagnostic Test: ROSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
the proportion of patients with adequate tissue for diagnosis
Measured: 1 month after Procedure
Secondary outcomes (1)
morbidity rate
Procedure-related morbidity
Measured: 1 month after Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start19 Jun 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Model description
- International multicenter prospective randomized comparative study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charing Chong, MD, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766659
- Sponsor's protocol ID
- MORE
- Acronym
- MORE
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2018
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)
- ClinicalTrials.gov ID
- NCT03766659
- Acronym / sponsor ID
- MORE / MORE
- Conditions
- Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 6 Dec 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.
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.
In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.
Detailed description
The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- International multicenter prospective randomized comparative study.
| Arm | Type | Receives |
|---|---|---|
| MOSE | Other | Diagnostic Test: MOSEEUS-FNB with MOSE |
| ROSE | Other | Diagnostic Test: ROSEEUS-FNA with ROSE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 18 and 80 years
- Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter
Key exclusion criteria (5 listed)
- Coagulopathy
- Altered anatomy
- Contraindications for conscious sedation
- Pregnancy
- Those who cannot provide informed consent
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 |
|---|---|---|
| MOSEEUS-FNB with MOSE | Diagnostic test | MOSE |
| ROSEEUS-FNA with ROSE | Diagnostic test | ROSE |
Primary outcome
Diagnostic yield
Time frame: 1 month after Procedure
the proportion of patients with adequate tissue for diagnosis
1 secondary outcome
morbidity rate
Time frame: 1 month after Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
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 and ROSE in people with Pancreatic Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 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 13 Feb 2023. 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 Hong Kong. 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 Charing CHONG (3505 3933, chongcn@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 1 month after Procedure). 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 13 Feb 2023.