Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
Necrotizing PancreatitisWalled Off NecrosisThe research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
Acute PancreatitisSystemic Inflammatory Response SyndromeThis open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.
Comparing the Effects of Lactated Ringers and Normal Saline in Acute Pancreatitis
PancreatitisAcute pancreatitis is increasingly common diagnosis in children. Most of the guidelines related to the details of management of acute pancreatitis are extrapolated from the adult literature. There is only limited data regarding management of acute pancreatitis in children. The mainstay of management is bowel and pancreatic rest with significant fluid support to minimize the effect of the cytokines on the pancreas and other organs. The standard fluid choices are Lactated Ringer's solution (LR) and normal saline (NS). Currently, both LR and NS are used at the discretion of the treating physician as the standard of care for acute pancreatitis. The investigators hope to examine the question of ideal fluid choice for fluid resuscitation in children with acute pancreatitis by assessing recovery time in the context of measured inflammatory markers and SIRS status at 24 and 48 hours after admission. The ideal fluid choice in the initial resuscitation of acute pancreatitis has not been effectively evaluated before in the pediatric population. Even if there is no statistically significant difference between the two fluid options, this trial will still provide clinically significant information.
Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain
CannabinoidTetrahydrocannabinol2 moreThe main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.
Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
Pancreatic NeoplasmsBiliary Tract Neoplasms3 morePancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "nonstented stump-closed pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.
Moderate Versus Aggressive Fluids for Acute Pancreatitis
PancreatitisFluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is associated with necrosis. However, there is insufficient evidence to support whether resuscitation should be moderate or aggressive. In this study the investigators aim to compare the clinical outcome associated with these strategies in a clinical randomized fashion to determine the optimal treatment of acute pancreatitis.
Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in...
Severe Acute Pancreatitis PatientsDuodenal Fistula1 moreDifferent studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.
Pancreatic Metal Stents in Chronic Pancreatitis
Refractory Pancreatic Duct StricturesPainful Chronic PancreatitisThe purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.
Rituximab in IgG4-RD: A Phase 1-2 Trial
Retroperitoneal FibrosisAutoimmune Pancreatitis2 moreThe primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
PancreatitisChronic2 moreAbdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.