5 Clinical Trials for Various Conditions
This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component \>30%.
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas. For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).
The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.