Back to resultsComparison of FCSEMS and Plastic Stents (WON-MVP)
Primary Purpose
Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FCSEM Stent
Plastic Stent
Sponsored by
About this trial
This is an interventional treatment trial for Infected Pancreatic Necrosis focused on measuring pancreatic fluid collection; pancreatic necrosis; stent;
Eligibility Criteria
Inclusion Criteria:
- The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
- The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- Males or females ≥ 18 years of age.
- WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).
- WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall
- Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum White Blood Cells ≥ 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) ≥ 4 weeks from attack of acute pancreatitis.
Documented history of acute or chronic pancreatitis:
i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:
- Abdominal pain characteristic of acute pancreatitis
- Serum lipase/amylase ≥ x3 upper limit of normal
- Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (≥5/9 of Rosement criteria)
- Able to undergo general anesthesia
Exclusion Criteria:
- Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin testing.
- Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
- Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
- Age < 18 years
- Unable to obtain consent for the procedure from either the patient or LAR
- Use of anticoagulants that cannot be discontinued for the procedure
- Unable to tolerate general anesthesia
- WON that is not accessible for EUS-guided drainage
- Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
Sites / Locations
- Center for Interventional Endoscopy - Florida Hospital Orlando
- Florida Hospital Center for Interventional Endoscopy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FCSEM Stent
Plastic Stents
Arm Description
WON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen.
WON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity.
Outcomes
Primary Outcome Measures
The number of interventions performed between metal and plastic stent groups to achieve treatment success
The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.
Secondary Outcome Measures
Technical success
Successful deployment of transmural stents in to the WON cavity.
Treatment success
Resolution of WON on CT scan and resolution of symptoms at 6-week outpatient follow-up (from day of hospital discharge) WITHOUT the need for cross-over to minimally invasive surgical debridement
Treatment failure
Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage or underlying diseaseor underlying disease.
Recurrence
Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
Procedure duration (minutes)
Time from start of the procedure (endoscope inserted into the gastrointestinal lumen to perform transmural drainage to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).
Adverse events
Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
Duration of hospitalization
Day of procedure to the day of hospital discharge
Cost Analysis (Inpatient and outpatient costs)
Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02685865
Brief Title
Comparison of FCSEMS and Plastic Stents
Acronym
WON-MVP
Official Title
Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2016 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.
Detailed Description
The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection, Symptomatic Pancreatic Necrosis
Keywords
pancreatic fluid collection; pancreatic necrosis; stent;
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FCSEM Stent
Arm Type
Active Comparator
Arm Description
WON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen.
Arm Title
Plastic Stents
Arm Type
Active Comparator
Arm Description
WON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity.
Intervention Type
Device
Intervention Name(s)
FCSEM Stent
Other Intervention Name(s)
Fully covered self-expandable metal stent
Intervention Description
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
Intervention Type
Device
Intervention Name(s)
Plastic Stent
Intervention Description
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific
Primary Outcome Measure Information:
Title
The number of interventions performed between metal and plastic stent groups to achieve treatment success
Description
The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Technical success
Description
Successful deployment of transmural stents in to the WON cavity.
Time Frame
at index treatment Day 0
Title
Treatment success
Description
Resolution of WON on CT scan and resolution of symptoms at 6-week outpatient follow-up (from day of hospital discharge) WITHOUT the need for cross-over to minimally invasive surgical debridement
Time Frame
6 week
Title
Treatment failure
Description
Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage or underlying diseaseor underlying disease.
Time Frame
6 months
Title
Recurrence
Description
Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
Time Frame
6 months
Title
Procedure duration (minutes)
Description
Time from start of the procedure (endoscope inserted into the gastrointestinal lumen to perform transmural drainage to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).
Time Frame
at index treatment Day 0
Title
Adverse events
Description
Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
Time Frame
6 months
Title
Duration of hospitalization
Description
Day of procedure to the day of hospital discharge
Time Frame
6 months
Title
Cost Analysis (Inpatient and outpatient costs)
Description
Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
Males or females ≥ 18 years of age.
WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).
WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall
Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum White Blood Cells ≥ 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) ≥ 4 weeks from attack of acute pancreatitis.
Documented history of acute or chronic pancreatitis:
i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:
Abdominal pain characteristic of acute pancreatitis
Serum lipase/amylase ≥ x3 upper limit of normal
Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (≥5/9 of Rosement criteria)
Able to undergo general anesthesia
Exclusion Criteria:
Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin testing.
Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
Age < 18 years
Unable to obtain consent for the procedure from either the patient or LAR
Use of anticoagulants that cannot be discontinued for the procedure
Unable to tolerate general anesthesia
WON that is not accessible for EUS-guided drainage
Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyam Varadarajulu, MD
Organizational Affiliation
Florida Hospital Orlando
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Interventional Endoscopy - Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Hospital Center for Interventional Endoscopy
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of FCSEMS and Plastic Stents
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