Gastroenterology and Hepatology

Below are current clinical trials.

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

1. 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.

2. Cologuard Cohort Study

   Rochester, Minn.

   The purpose of this study is to develop a health services registry and repository to prospectively examine patient use of health services and related health outcomes over time among a cohort of adults who have had an order placed for Cologuard.

3. A Study to Assess Gastric Functions

   Rochester, Minn.

   The purposes of this study are to assess gastric motility and emptying with scintigraphy in patients with upper gastrointestinal symptoms, to evaluate the relationship between daily symptoms and GE, motility, and symptoms during a GE study, to assess fasting and postprandial gastric volumes and motility with MRI in patients with upper gastrointestinal symptoms, and to compare gastric motility measured with scintigraphy and MRI.

    

4. Study to Evaluate Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The purpose of this study is to investigate if Hybrid Argon Plasma Coagulation (HAPC) is non-inferior to Radiofrequency Ablation (RFA) in the stricture-free eradication of the dysplastic Barrett's Esophagus (BE) epithelium.

    

5. 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.

6. A Study Establishing a Registry for Endoscopic Suturing (ES)

   Jacksonville, Fla.

   The purpose of this study is to determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable. To evaluate the effectiveness, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.

7. Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

   Rochester, Minn.

   The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric patients with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric patients with IBS-D.

    

    

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8. 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.

9. Fecal Microbiome Transplant National Registry

   Rochester, Minn.

   The overarching goal of the FMT registry is to expand knowledge and optimize practice in the transplantation of fecal microbiota or other gut-related-microbiota products.

10. Tissue Collection for Patients with Cancers other than Hepatobilairy Cancers with Metastasis to the Liver

    Rochester, Minn.

    The goal of this study is to develop a resource (bank) of biospecimens (blood, tissue) from patients having cancers that metastasis to the liver. The purpose of the resource bank is to facilitate studies on the pathogenesis of cancers metastasizing to the liver and also in order to assess the ability of new tests to detect early cancer in the cohort of patients undergoing routine surveillance for cancer. The biospecimens will include cultures of tumor cells and tumor-associated non-malignant cells, as well as xenografts established from freshly isolated metastatic cancers in immunodeficient mice. We plan to administer a risk factor questionnaire to facilitate identification of risk factors for development of metastatic liver cancer. The study will also  determine survival of patients from time of diagnosis.