Pancreatic Pseudocysts
Conditions
Brief summary
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
Interventions
PROCEDUREEndoscopy
Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years or older 2. Subject has pancreatic pseudocyst 3. Subject has medical indication for drainage of the pancreatic pseudocyst 4. Subject must be able to give informed consent
Exclusion criteria
1. Any contraindication to endoscopic pseudocyst drainage 2. Subject is unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen | baseline | Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst . Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst. |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). | 6 to 12 weeks after baseline |
| Adverse Events | 1 year |
Countries
United States
Participant flow
Pre-assignment details
There were 22 signed informed consents, however after Endoscopic ultrasound imaging, 2 participants were excluded due to characteristics of the cyst cavity. Therefore, 20 participants underwent transgastric drainage of pancreatic pseudocysts by use of the fully covered self-expanding metal stents (CSEMS).
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Pseudocysts Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pancreatic Pseudocysts |
|---|---|
| Age, Continuous | 57 years |
| Pseudocyst diameter | 13.4 centimeters |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen
Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst . Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.
Time frame: baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pancreatic Pseudocysts | Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen | technical success | 20 participants |
| Pancreatic Pseudocysts | Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen | technical failure | 0 participants |
Secondary
Adverse Events
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pancreatic Pseudocysts | Adverse Events | Pseudocyst infection requiring surgery | 2 participants |
| Pancreatic Pseudocysts | Adverse Events | Posttransmural drainage fever | 1 participants |
| Pancreatic Pseudocysts | Adverse Events | PostEndoscopic retrograde cholangiopancreatography | 1 participants |
Secondary
Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).
Time frame: 6 to 12 weeks after baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pancreatic Pseudocysts | Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). | Resolution of Pseudocyst | 17 participants |
| Pancreatic Pseudocysts | Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). | Unresolved Pseudocyst | 3 participants |