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

NCT ID: NCT03169842

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-25

Study Completion Date

2022-04-18

Brief Summary

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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

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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

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Pancreatic Cyst

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cyst fluid glucose

Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate

Group Type EXPERIMENTAL

pancreatic cyst fluid glucose analysis using a bedside glucometer

Intervention Type DEVICE

Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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2016.227.C

Identifier Type: -

Identifier Source: org_study_id

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