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Comparison of FCSEMS and Plastic Stents (WON-MVP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685865
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

Tracking Information
First Submitted Date  ICMJE November 24, 2015
First Posted Date  ICMJE February 19, 2016
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE February 12, 2016
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
The number of interventions performed between metal and plastic stent groups to achieve treatment success [ Time Frame: 6 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
The number of re-interventions performed between metal and plastic stent groups to achieve treatment success [ Time Frame: 6 weeks ]
The primary objective of this study is to compare the number of re-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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Technical success [ Time Frame: at index treatment Day 0 ]
    Successful deployment of transmural stents in to the WON cavity.
  • Treatment success [ Time Frame: 6 week ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
  • Procedure duration (minutes) [ Time Frame: at index treatment Day 0 ]
    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 [ Time Frame: 6 months ]
    Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
  • Duration of hospitalization [ Time Frame: 6 months ]
    Day of procedure to the day of hospital discharge
  • Cost Analysis (Inpatient and outpatient costs) [ Time Frame: 6 months ]
    Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
  • Technical success [ Time Frame: at index treatment Day 0 ]
    Successful deployment of transmural stents in to the WON cavity.
  • Treatment success [ Time Frame: 6 week ]
    Decrease in the size of WON to <33% of the original size 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 [ Time Frame: 6 months ]
    Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage
  • Recurrence [ Time Frame: 6 months ]
    Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
  • Procedure duration (minutes) [ Time Frame: at index treatment Day 0 ]
    Time from start of the procedure (endoscope inserted into the oropharynx) to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).
  • Adverse events [ Time Frame: 6 months ]
    Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
  • Duration of hospitalization [ Time Frame: 6 months ]
    Day of procedure to the day of hospital discharge
  • Cost Analysis (Inpatient and outpatient costs) [ Time Frame: 6 months ]
    Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of FCSEMS and Plastic Stents
Official Title  ICMJE Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infected Pancreatic Necrosis
  • Acute Pancreatic Fluid Collection
  • Pancreatic and Peripancreatic Necrosis
  • Pancreatic Collection
  • Symptomatic Pancreatic Necrosis
Intervention  ICMJE
  • Device: FCSEM Stent
    Hot Axios Fully covered self-expandable metal stent - Boston Scientific
    Other Name: Fully covered self-expandable metal stent
  • Device: Plastic Stent
    7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific
Study Arms  ICMJE
  • Active Comparator: FCSEM Stent
    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.
    Intervention: Device: FCSEM Stent
  • Active Comparator: Plastic Stents
    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: Device: Plastic Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2016)
62
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
  2. 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.
  3. Males or females ≥ 18 years of age.
  4. 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).
  5. 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
  6. 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.
  7. Documented history of acute or chronic pancreatitis:

    i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:

    1. Abdominal pain characteristic of acute pancreatitis
    2. Serum lipase/amylase ≥ x3 upper limit of normal
    3. 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)
  8. Able to undergo general anesthesia

Exclusion Criteria:

  1. 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.
  2. Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
  3. Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
  4. Age < 18 years
  5. Unable to obtain consent for the procedure from either the patient or LAR
  6. Use of anticoagulants that cannot be discontinued for the procedure
  7. Unable to tolerate general anesthesia
  8. WON that is not accessible for EUS-guided drainage
  9. Percutaneous drainage of WON is required or performed prior to EUS-guided drainage
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02685865
Other Study ID Numbers  ICMJE 837579
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Florida Hospital
Study Sponsor  ICMJE Florida Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shyam Varadarajulu, MD Florida Hospital Orlando
PRS Account Florida Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP