Comparison of FCSEMS and Plastic Stents (NCT02685865) | Clinical Trial Compass
CompletedNot Applicable
Comparison of FCSEMS and Plastic Stents
United States60 participantsStarted 2016-02-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. Abdominal pain characteristic of acute pancreatitis
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.
What they're measuring
1
The number of interventions performed between metal and plastic stent groups to achieve treatment success