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Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169842
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ochsner Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cyst Device: pancreatic cyst fluid glucose analysis using a bedside glucometer Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Cyst fluid glucose
Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate
Device: pancreatic cyst fluid glucose analysis using a bedside glucometer
Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to perform pancreatic cyst fluid sampling
  • <1mL of cyst fluid is aspirated during EUS-FNA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169842


Contacts
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Contact: Maria Gloth, CCRC 504-842-2417 mgloth@ochsner.org

Locations
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United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Maria Gloth, CCRC    504-842-2417    mgloth@ochsner.org   
Contact: Janak N Shah, MD       janak.shah@ochsner.org   
Principal Investigator: Janak N Shah, MD         
Sponsors and Collaborators
Ochsner Health System

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Responsible Party: Ochsner Health System
ClinicalTrials.gov Identifier: NCT03169842    
Other Study ID Numbers: 2016.227.C
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases