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The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Pseudocysts | All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy | Procedure | Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have a medical indication for endoscopic drainage of pancreatic pseudocyst and are referred for the procedure as part of their standard medical care will be considered for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Peter V draganov, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands UF Endoscopy | Gainesville | Florida | 32608 | United States |
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). | Posted | Number | participants | 6 to 12 weeks after baseline |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pseudocyst infection requiring surgery | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Major complication from transmural drainage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| posttransmural drainage fever | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter V. Draganov | University of Florida | (352) 273-9472 | Peter.Draganov@medicine.ufl.edu |
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| ID | Term |
|---|---|
| D010192 | Pancreatic Pseudocyst |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pseudocyst diameter | Mean | Full Range | centimeters |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Number | participants | baseline |
|
|
|
| Secondary | Adverse Events | Posted | Number | participants | 1 year |
|
|
|
| 2 |
| 20 |
| 1 |
| 20 |
|
| post-ERCP pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D013514 | Surgical Procedures, Operative |
| Title | Measurements |
|---|---|
|