Clinical Trials

Acute pancreatitis (AP) is the most common gastrointestinal cause of hospital admission resulting in an estimated $2.6 billion per year in costs. Each year, there are more than 300,000 admissions to the hospital for treatment of AP. The incidence of AP is rising and hospital admissions due to pancreatitis have increased by at least 15% over the past 10 years. Unfortunately, despite over 100 years of experimental and clinical studies, there are still no targeted drugs available to treat this painful condition. Current treatment is limited to supportive care such as fluids, nutrition, and pain control and complication management. Although the mechanisms of AP remain unclear, pathologic intra-acinar trypsinogen activation plays important roles in the disease initiation and progression. Clinically, however, medications targeting trypsin alone have not been effective in treating AP patients. Recently, we have found pre-treatment with Dabigatran, an FDA approved drug for anticoagulation which not only inhibits thrombin but also trypsin, dramatically alleviated pancreatic edema, serum amylase levels and pancreas histology. In contrast, Camostat, a trypsin inhibitor which is used in other countries for AP, has limited effects. In addition, 5-20 hours after AP induction, Dabigatran, but not Camostat, effectively prevented parenchymal cell death and the development of chronic pancreatitis. Our study suggested that coagulation may be a novel mechanism for AP initiation and progression. We retrospectively studied the role of anti-coagulation in AP using the Nationwide Inpatient Sample (NIS) 2014. After matched by gender and age, comorbidity index, patients who were on anti-coagulation for their pre-existing condition had lower mortality, fewer ICU admissions, fewer complications, shorter hospital stay and lower hospital costs than those who were not on anti-coagulations. Therefore, anti-coagulation is a promising treatment for AP.

The purpose of this study is to assess the physiologic effect of orally administered indomethacin (IN) on pancreatic juice PGE2 concentrations in patients with chronic pancreatitis (CP).

This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN.

The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.

Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission.

Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.

The purpose of this study are 1) to refine an existing internet-delivered pain self-management program for use in adult chronic pancreatitis (CP) patients, and 2) to pilot its use in this patient population, generating preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial. 

The purpose of this study is to determine the safety and efficacy of NI-03.

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%.

Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening. Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct.

The more attempts to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle can increase the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct, then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.

The aim of this pragmatic, randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature into a contained necrotic collection, typically four weeks into the disease course. With intense conservative management, including nutritional and intensive care support when required, the collection may resolve without intervention. However, a persistent collection with pain, gastric outlet, intestinal or biliary obstruction, new-onset or persisting organ failure, persistent unwellness or infection is associated with a mortality of 15-20%, and requires necrosectomy and drainage. Without intervention, infected necrosis ultimately leads to death in nearly every patient.

Recently, there has been a shift away from surgical debridement (necrosectomy) towards minimally-invasive endoscopic methods in the treatment of necrotizing pancreatitis. Endoscopic management involves creation of a fistula between the enteric wall and necrotic collection under the guidance of endoscopic ultrasound [EUS] with subsequent placement of a stent to allow drainage of the necrotic material. Endoscopic transenteral drainage of necrotic collection is associated with favorable outcomes, with treatment success rates reported in the range of 45-70%. Endoscopic necrosectomy, with the additional technique of extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.

The purpose of this study is to evaluate the lateral flow assay (LFA) to be used in conjunction with imaging and existing biomarkers in diagnosed or at-risk-for pancreatic cancer patients.

The purpose of this study is to determine the safety, tolerability and dose-limiting toxicity of adding lacosamide to opioid therapy for the treatment of abdominal pain due to chronic pancreatitis (CP). Also, to assess the feasibility of performance of a pilot study adding lacosamide to opioid therapy in these subjects.