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

Not Applicable

Completed

• Conditions: Pancreatic Cyst
• Interventions: Device: pancreatic cyst fluid glucose analysis using a bedside glucometer

• Registration Number: NCT03169842
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-25
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyst fluid glucose	pancreatic cyst fluid glucose analysis using a bedside glucometer	Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate

Primary Outcome Measures

Name	Time	Method
Cyst fluid glucose level	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

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States