Pancreatic CystNCT03169842
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
A study testing pancreatic cyst fluid glucose analysis using a bedside glucometer in people with Pancreatic Cyst, run by Ochsner Health System at 1 site in United States.
Trial summary
This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- pancreatic cyst fluid glucose analysis using a bedside glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 18 Apr 2022
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
- Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study
Who cannot join
- Inability to perform pancreatic cyst fluid sampling
- <1mL of cyst fluid is aspirated during EUS-FNA
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Official title: Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts
This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.
Read the detailed description
Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.
For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.
Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).
- Conditions
- Pancreatic Cyst
- Being tested
- pancreatic cyst fluid glucose analysis using a bedside glucometer
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic cyst fluid glucose analysis using a bedside glucometerDevice
Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.
| Study group | Role | What they receive |
|---|---|---|
| Cyst fluid glucose | Experimental | Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate Receives: Device: pancreatic cyst fluid glucose analysis using a bedside glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyst fluid glucose level
concentration of cyst fluid glucose based on measurement with bedside glucometer
Measured: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start25 May 2017
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169842
- Sponsor's protocol ID
- 2016.227.C
- Status last verified
- Oct 2022
- First submitted
- 25 May 2017
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts
- ClinicalTrials.gov ID
- NCT03169842
- Acronym / sponsor ID
- 2016.227.C
- Conditions
- Pancreatic Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 30 May 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.
This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.
Detailed description
Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.
For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.
Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyst fluid glucose | Experimental | Device: pancreatic cyst fluid glucose analysis using a bedside glucometerSingle arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
- Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study
Key exclusion criteria (2 listed)
- Inability to perform pancreatic cyst fluid sampling
- <1mL of cyst fluid is aspirated during EUS-FNA
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 |
|---|---|---|
| pancreatic cyst fluid glucose analysis using a bedside glucometerSmall amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures. | Device | Cyst fluid glucose |
Primary outcome
Cyst fluid glucose level
Time frame: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid
concentration of cyst fluid glucose based on measurement with bedside glucometer
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 5 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cyst
Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Pancreatic Cyst
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 pancreatic cyst fluid glucose analysis using a bedside glucometer in people with Pancreatic Cyst, run by Ochsner Health System 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 2 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 5 Oct 2022. 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?
Cyst fluid glucose level (time frame: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid). 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 5 Oct 2022.