Clinical Research Directory

Necrosectomy With Cryotechnology for Accelerated Removal

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.

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System

Goal: The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis. Participant Population: The study will involve adult patients experiencing symptomatic WON due to acute necrotizing pancreatitis. Main Questions: The main questions it aims to answer are: 1. Is "endoscopy" or direct endoscopic necrosectomy (DEN) with powered endoscopic debridement (PED) as effective as "surgery" or transgastric surgical necrosectomy (SN) in achieving clinical resolution of WON within six weeks after treatment? 2. What are the rates of complications, costs, hospital length of stay, procedure time, readmission, repeat procedures and overall patient satisfaction associated with DEN with PED compared to transgastric SN? Comparison Group: Researchers will compare the outcomes of patients receiving DEN with PED to those undergoing transgastric SN to see if there are significant differences in clinical success, rates of complications, and overall healthcare costs. Participants Will: 1. Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN). 2. Undergo the assigned treatment procedure based on their group. 3. Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction. 4. Be monitored for adverse events or complications following the treatment

Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.