GastroenterologyNCT02979509
Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
An observational study of Gastroenterology and Lesions, run by University of Florida at 1 site in United States.
Trial summary
All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroenterology, Lesions
- What is being tested?
- Endoscopic ultrasound- (EUS) guided tissue sampling
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Aug 2019
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include all patients who are scheduled to undergo EUS-guided tissue sampling as part of their standard of care.
Who may be able to join
- Age >18 years old
- Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
- Target lesion should be ≥ 15 mm in size (long axis).
Who cannot join
- Any contraindication to performing endoscopy
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles.
Read the detailed description
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.
Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
- Conditions
- Gastroenterology, Lesions
- Being tested
- Endoscopic ultrasound- (EUS) guided tissue sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound- (EUS) guided tissue samplingOther
Also called EUS-TS
EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ultrasound- (EUS) guided tissue sampling | All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study. Receives: Other: Endoscopic ultrasound- (EUS) guided tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic yield of EUS-TS
Measured: 2 months
Secondary outcomes (6)
Diagnostic Yield of EUS-guided tissue sampling solid lesions
Measured: 2 months
Diagnostic Yield of EUS-guided tissue sampling cystic lesions
Measured: 2 months
Diagnostic yield of EUS-TS using through-the-needle micro forceps
Measured: 2 months
Diagnostic yield of EUS-TS using fine-needle aspiration
Measured: 2 months
Diagnostic yield of EUS-TS using core biopsy needle
Measured: 2 months
Rate of adverse events associated with EUS-TS
Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJun 2016
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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 GastroenterologyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Borland Groover Clinic, Jacksonville, FL, Northwestern University, Mayo Clinic, Montefiore Medical Center, Bronx, NY, Columbia University, Johns Hopkins University, New York University, Yale University, Geisinger Medical Center, Danville, PA, Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Dennis Yang, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979509
- Sponsor's protocol ID
- IRB201600783
- Status last verified
- Jan 2020
- First submitted
- 29 Nov 2016
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.
Publications
Yang D, Trindade AJ, Yachimski P, Benias P, Nieto J, Manvar A, Ho S, Esnakula A, Gamboa A, Sethi A, Gupte A, Khara HS, Diehl DL, El Chafic A, Shah J, Forsmark CE, Draganov PV. Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1587-1596. doi: 10.1016/j.cgh.2018.11.027. Epub 2018 Nov 22.
PubMed 30471456
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
- ClinicalTrials.gov ID
- NCT02979509
- Acronym / sponsor ID
- IRB201600783
- Conditions
- Gastroenterology, Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Borland Groover Clinic, Jacksonville, FL, Northwestern University, Mayo Clinic, Montefiore Medical Center, Bronx, NY, Columbia University, Johns Hopkins University, New York University, Yale University, Geisinger Medical Center, Danville, PA, Ochsner Health System
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles.
Detailed description
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.
Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ultrasound- (EUS) guided tissue sampling | – | Other: Endoscopic ultrasound- (EUS) guided tissue samplingAll patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all patients who are scheduled to undergo EUS-guided tissue sampling as part of their standard of care.
Key inclusion criteria (3 listed)
- Age >18 years old
- Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
- Target lesion should be ≥ 15 mm in size (long axis).
Key exclusion criteria (2 listed)
- Any contraindication to performing endoscopy
- Unable to 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 |
|---|---|---|
| Endoscopic ultrasound- (EUS) guided tissue samplingAlso: EUS-TSEUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care. | Other | Endoscopic ultrasound- (EUS) guided tissue sampling |
Primary outcome
Overall diagnostic yield of EUS-TS
Time frame: 2 months
6 secondary outcomes
Diagnostic Yield of EUS-guided tissue sampling solid lesions
Time frame: 2 months
Diagnostic Yield of EUS-guided tissue sampling cystic lesions
Time frame: 2 months
Diagnostic yield of EUS-TS using through-the-needle micro forceps
Time frame: 2 months
Diagnostic yield of EUS-TS using fine-needle aspiration
Time frame: 2 months
Diagnostic yield of EUS-TS using core biopsy needle
Time frame: 2 months
Rate of adverse events associated with EUS-TS
Time frame: 48 hours
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 Jan 2020.
- Derived from this study: PubMed 30471456Yang D, Trindade AJ, Yachimski P, Benias P, Nieto J, Manvar A, Ho S, Esnakula A, Gamboa A, Sethi A, Gupte A, Khara HS, Diehl DL, El Chafic A, Shah J, Forsmark CE, Draganov PV. Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1587-1596. doi: 10.1016/j.cgh.2018.11.027. Epub 2018 Nov 22.
- Individual participant dataSharing planned: Yes. Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.
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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.
Dennis Yang, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenterology and Lesions, run by University of Florida at 1 site in United States.
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 3 inclusion and 2 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 Jan 2020. 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 United States. 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?
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?
Overall diagnostic yield of EUS-TS (time frame: 2 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 NCT02979509, 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 Jan 2020.