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Physician-scientists at IU School of Medicine conduct ground-breaking research studies to understand diseases of the pancreas.

Diseases of the Pancreas Research Studies

Investigators

Mohammad A. Al-Haddad, M.D.

Naga P. Chalasani Professor of Gastroenterology and Hepatology

Jeffrey J. Easler, MD

Associate Professor of Medicine

Evan L. Fogel, MD

Stuart Sherman Professor of Gastroenterology

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%.

View the study on clinicaltrials.gov

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study)

Enrolling: Yes

Principle Investigator: Evan Fogel, MD

Primary Objectives:

  1. To establish a model longitudinal research cohort of adult patients for the study of chronic pancreatitis and its complications.
  2. 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.
  3. To test the predictive capability of candidate biomarkers for diagnosis and prognosis of chronic pancreatitis.
  4. 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.

View the study on clinicaltrials.gov

Predicting treatment response in Chronic Pancreatitis using Quantitative Sensory Testing

Enrolling: Yes

Principle Investigator: Jeffrey Easler, MD

Primary Objective:  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.

View the study on clinicaltrials.gov

Extracorporeal shockwave lithotripsy versus single operator pancreatoscopy and intraductal lithotripsy for the treatment of pancreatic duct stones

Enrolling: Yes

Principle Investigator: Jeffrey Easler, MD

Primary Objective: Obtain pilot data to determine the optimal method of clearing large main pancreatic duct stones.

View the study on clinicaltrials.gov

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.

View the study on clinicaltrials.gov

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts (CHARM)

Enrolling: Yes

Principle Investigator: John DeWitt, MD

Primary Objective: Evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.

View the study on clinicaltrials.gov

Pancreatic Cyst Fluid Specimen Collection and Storage for Research Use (De-identified leftover clinical specimens)

Enrolling: Yes

Principal Investigator: Mohammad Al-Haddad, MD

Primary Objective: Establish a biorepository to store leftover human specimens for use in the research and development and validation of diagnostic products.

Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis (CPN)

Enrolling: Yes

Principal Investigator: Mohammad Al-Haddad, MD

Primary Objective: Collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management.

View the study on clinicaltrials.gov

Diabetes RElated to Acute Pancreatitis and Its Mechanisms (DREAM)

Enrolling: Yes

Principle Investigator: Evan Fogel, MD

Primary Objective: Conduct a prospective longitudinal (36 months) observational clinical study to investigate the incidence, etiology, and pathophysiology of diabetes mellitus (DM) following acute pancreatitis (AP).

View the study on clinicaltrials.gov

Closed Research Studies for the Diseases of the Pancreas

  • A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 (Tactic)

    Enrolling: No

    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.

    Clinicaltrials.gov

  • Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPIRE 2)

    Enrolling: No

    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.

    Clinicaltrials.gov