NCT03169842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

4.9 years

First QC Date

May 25, 2017

Last Update Submit

October 3, 2022

Conditions

Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

  • Cyst fluid glucose level

    concentration of cyst fluid glucose based on measurement with bedside glucometer

    immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid

Study Arms (1)

Cyst fluid glucose

EXPERIMENTAL

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

Device: pancreatic cyst fluid glucose analysis using a bedside glucometer

Interventions

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.

Cyst fluid glucose

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

May 25, 2017

Primary Completion

April 18, 2022

Study Completion

April 18, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)