Gastroenterology and Hepatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Study Evaluating the Safety and Feasibility of Using Human Cell Therapy for the Treatment of Aerodigestive Fistulae in Adults

   Jacksonville, Fla.

   The purpose of this study is to evaluate the feasibility, time, cost, safety, limitations, and efficacy of the use of institutionally processed SVF for management and closure of aero-digestive fistulae.

2. Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram

   Rochester, Minn.

   A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information but yet is not available non-invasively. Recent murine studies from this group of investigators has identified that MRE technology can be adapted to non-invasively detect these conditions. Implementing this into the practice will transform it by obviating the need for invasive liver biopsies in patients suspected of having such forms of suspected liver disease. This will differentiate Mayo from other institutions where such technology is not available.

   An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of obesity. Recent evidence indicates a potential link between OSA and severity of NASH and fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD is unclear. This study offers the unique opportunity to analyze this association, as the study population will undergo routine evaluation for OSA, as part as the preoperative work-up prior to bariatric surgery.

3. Phase II Study of EUS-guided Verteporfin PDT in Solid Pancreatic Tumors

   Jacksonville, Fla., Rochester, Minn.

   The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a photodynamic therapy (PDT) to evaluate response of tumor.

4. Whole Exome Sequencing and Other Emerging Technologies of Endoscopic Ultrasound Cytopathology

   Rochester, Minn.

   The purpose of this research study is to gather information on the feasibility of performing novel molecular analysis on Endoscopic Ultrasound acquired cytologic material and to assess molecular changes in cytology samples to see if that may aid treatment decision planning for future patients.

5. A Study to Establish Initial Case Series with Exalt Single-Use Duodenoscope

   Rochester, Minn.

   The purpose of this study is to confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

6. Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

7. REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma

   Rochester, Minn.

   The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.

8. Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

   Rochester, Minn.

   This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.

9. A Dose Ranging Study Evaluating Efficacy and Safety of NI-03

   Scottsdale/Phoenix, Ariz.

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

10. Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

    Rochester, Minn.

    To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.