Pancreatic Cysts
Conditions
Keywords
Pancreatic cysts incidentally found during EUS
Brief summary
The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.
Detailed description
The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The inclusion criteria included: patients \>18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass.
Exclusion criteria
* Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct * Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas * Laboratory and/or clinical evidence of ongoing acute pancreatitis * Previous pancreatic surgical resection * Pregnancy * Incarceration * High risk for sedation * Coagulopathy and/or thrombocytopenia * The patients underwent a complete EUS examination of the pancreas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Pancreatic Cysts During Routine EUS | 48 months | The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Undergoing EUS Patients undergoing EUS for non-pancreatic treatment.
Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies. | 341 |
| Total | 341 |
Baseline characteristics
| Characteristic | Patients Undergoing EUS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 113 Participants |
| Age, Categorical Between 18 and 65 years | 228 Participants |
| Region of Enrollment United States | 341 participants |
| Sex: Female, Male Female | 187 Participants |
| Sex: Female, Male Male | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 314 |
| serious Total, serious adverse events | 0 / 341 |
Outcome results
Primary
Prevalence of Pancreatic Cysts During Routine EUS
The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .
Time frame: 48 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Undergoing EUS | Prevalence of Pancreatic Cysts During Routine EUS | 46 participants found to have a cyst |