Comparison of FCSEMS and Plastic Stents

Study Overview
=================
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.

Official Title
-----------------
Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis

Conditions
-----------------
Infected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection, Symptomatic Pancreatic Necrosis

Intervention / Treatment
-----------------
* Device: FCSEM Stent
* Device: Plastic Stent


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FCSEM Stent<br>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. | Device: FCSEM Stent<br>* Hot Axios Fully covered self-expandable metal stent - Boston Scientific<br>* Other names: Fully covered self-expandable metal stent;|
| Active Comparator: Plastic Stents<br>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. | Device: Plastic Stent<br>* 7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful deployment of transmural stents in to the WON cavity. | at index treatment Day 0 | 
| 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 | 6 week | 
| 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. | 6 months | 
| Recurrence | Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success | 6 months | 
| 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). | at index treatment Day 0 | 
| Adverse events | Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus. | 6 months | 
| Duration of hospitalization | Day of procedure to the day of hospital discharge | 6 months | 
| Cost Analysis (Inpatient and outpatient costs) | Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic fluid collection; pancreatic necrosis; stent;