Solid TumorNCT03130140
MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions
A study testing Macroscopic on-site evaluation in people with Solid Tumor, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Macroscopic on-site evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Feb 2016to 1 Sep 2018
- 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
- Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.
Who cannot join
- Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study
The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.
The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.
Read the detailed description
To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.
- Conditions
- Solid Tumor
- Being tested
- Macroscopic on-site evaluation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macroscopic on-site evaluationProcedure or surgery
Macroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture.
ControlOther
Conventional EUS-FNA
| Study group | Role | What they receive |
|---|---|---|
| Macroscopic on-site evaluation | Active comparator | EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation. Receives: Procedure: Macroscopic on-site evaluation |
| Control | Sham comparator | EUS-FNA perform with a 19-gauge needle with conventional techniques. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start26 Feb 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 244 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
- NCT03130140
- Sponsor's protocol ID
- 2015.511
- Status last verified
- Dec 2018
- First submitted
- 19 Apr 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Chong CCN, Lakhtakia S, Nguyen N, Hara K, Chan WK, Puri R, Almadi MA, Ang TL, Kwek A, Yasuda I, Doi S, Kida M, Wang HP, Cheng TY, Jiang Q, Yang A, Chan AWH, Chan S, Tang R, Iwashita T, Teoh AYB. Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial. Endoscopy. 2020 Oct;52(10):856-863. doi: 10.1055/a-1172-6027. Epub 2020 Jun 4.
PubMed 32498098
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03130140
- Acronym / sponsor ID
- 2015.511
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 26 Apr 2017 (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 technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.
The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.
Detailed description
To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macroscopic on-site evaluation | Active comparator | Procedure: Macroscopic on-site evaluationEUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation. |
| Control | Sham comparator | Other: ControlEUS-FNA perform with a 19-gauge needle with conventional techniques. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.
Key exclusion criteria (1 listed)
- Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
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 |
|---|---|---|
| Macroscopic on-site evaluationMacroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture. | Procedure or surgery | Macroscopic on-site evaluation |
| ControlConventional EUS-FNA | Other | Control |
Primary outcome
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
Time frame: 4 weeks
proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Derived from this study: PubMed 32498098Chong CCN, Lakhtakia S, Nguyen N, Hara K, Chan WK, Puri R, Almadi MA, Ang TL, Kwek A, Yasuda I, Doi S, Kida M, Wang HP, Cheng TY, Jiang Q, Yang A, Chan AWH, Chan S, Tang R, Iwashita T, Teoh AYB. Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial. Endoscopy. 2020 Oct;52(10):856-863. doi: 10.1055/a-1172-6027. Epub 2020 Jun 4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macroscopic on-site evaluation in people with Solid Tumor, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA (time frame: 4 weeks). 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 NCT03130140, which also lists 1 linked publication.
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 Dec 2018.