Diseases of the Pancreas Research Studies
Investigators
Open Research Studies for Diseases of the Pancreas
SpHincterotomy for Acute Recurrent Pancreatitis Trial (Sharp Trial)
Enrolling: Yes
Principle Investigator: Evan Fogel, MD
Primary Outcomes Measured: Reduce the risk of subsequent acute pancreatitis episodes by 33%.
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study)
Enrolling: Yes
Principle Investigator: Evan Fogel, MD
Primary Objectives:
- To establish a model longitudinal research cohort of adult patients for the study of chronic pancreatitis and its complications.
- To estimate the risk of progression from suspected to definite chronic pancreatitis, and the risk of new-onset diabetes or exocrine insufficiency in definite chronic pancreatitis, and how the risks are influenced by patient characteristics and conditions.
- To test the predictive capability of candidate biomarkers for diagnosis and prognosis of chronic pancreatitis.
- To develop a framework for conducting biomarker, genetic, and mechanistic studies using clinical information and the biorepository developed as part of the longitudinal research cohort.
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPIRE 2)
Enrolling: Yes
Principle Investigator: Brian McFerron, MD
Primary Objective: To comprehensively characterize the pediatric population with Acute Recurrent Pancreatitis (ARP) and Chronic Pancreatitis (CP) and determine predictors of early onset CP and its sequelae.
Predicting treatment response in Chronic Pancreatitis using Quantitative Sensory Testing
Enrolling: Yes
Principle Investigator: Benjamin Bick, MD
Primary Objective: To distinguish phenotypes characterized by segmental sensitization of the pancreatic viscerotome, and systematic sensitization with pathological central pain processing including augmented temporal summation and impaired descending pain inhibition.
Extracorporeal shockwave lithotripsy versus single operator pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones
Enrolling: Yes
Principle Investigator: Benjamin Bick, MD
Primary Objective: Obtain pilot data to determine the optimal method of clearing large main pancreatic duct stones
A Phase 1, Single Dose PK and Safety Study with NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 Compared to Placebo in Subjects with Chronic Pancreatitis
Enrolling: Yes
Principle Investigator: Glen Lehman, MD
Primary Objective: To determine the efficacy, PK and safety of three doses of NI-03 (100mg, 200mg, and 300mg) as compared to placebo when administered three times daily (TID) for 28 consecutive days in subjects with chronic pancreatitis.
Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT)
Enrolling: Yes
Principle Investigator: Zeb Saeed, MD
Primary Objectives:
1. Evaluate the pancreatic polypeptide response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
2. Evaluate the insulin and glucagon response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
3. Evaluate the incretin response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
4. Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases and long-standing DM or normoglycemia.