Treatment Trials

194 Clinical Trials for Various Conditions

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Evaluation of Outcomes From Treatment of Benign or Malignant Pancreatic Diseases
Description

This study will be a retrospective chart review of patients who have been diagnosed with the benign or malignant pancreatic disease under the practice of Dr. Rohan Jeyarajah, M.D., Dr. Houssam Osman M.D., and Dr. Edward Cho M.D., Sc.M. at Methodist Health System Hospital in Richardson, TX. The investigators plan to conduct an analysis of patients meeting the inclusion criteria from 2005 to present. Study will also be conducted by the PI, Sub-Is, surgery fellows, office staff and clinical research coordinator who are delegated to do by the PI. Data will be obtained by looking through either investigator's patients or through a national database. Data will be analyzed primarily by the study conductors.

Conditions

Benign or Malignant Pancreatic Diseases

Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Description

The purpose of this study is to collect blood samples to detect potential markers of pancreatic cancer in the blood and link these findings to medical and health information. Information from this study may help to provide insight into the detection of pancreas cancer in the blood before it can be found by other methods or provide a method of monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of this study is to collect blood to create a biobank.

Conditions

Pancreatic Diseases

EUS Ductal Evaluation in One Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease
Description

The purpose of this study is, to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for performing this combined technique. It is expected that combining these procedures will eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce total recovery time for the patient, and will decrease the associated costs of separate procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is compromised with diarrhea and weight loss. However, while most physicians can readily diagnose patients with severe CP, early CP or "minimal-change" CP is difficult to detect, often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a result, clinicians are searching for diagnostic tools which will allow for earlier, accurate detection of this disease, with the hope that appropriate therapy can be initiated before extensive thickening and scarring of the pancreas occurs. Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS), hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate) obtained from the duodenum (the part of the intestine where the stomach opens into the small bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need for biopsy or surgery. It is also sensitive in detecting mild disease. These procedures are standard of care (the normal care you would receive) for the evaluation of CP. The purpose of this study, is to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate endoscopic procedures.

Conditions

Pancreatic Disease

Biospecimens for Identification of Diseases of the Pancreas.
Description

This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.

Conditions

Pancreatic Cancer, Chronic Pancreatitis, Type II Diabetes, Pancreatic Cysts, Healthy Control

PANCREATIC DISEASE COHORT A Registry and Biospecimen Bank to Better Understand Pancreatic Disease
Description

The specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples. Therefore, no hypothesis is to be tested. The personal data derived from the registry, correlated with biological information derived from the biospecimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.

Conditions

Pancreatic Cancer

Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Description

RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.

Conditions

Familial Pancreatic Cancer

Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
Description

RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future. PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.

Conditions

Islet Cell Tumor, Pancreatic Cancer, Pancreatic Disease

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Description

This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Conditions

Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst, Gastrointestinal Tumor, Bile Duct Diseases, Bile Duct Cancer, Lymph Node Disease, Submucosal Tumor of Gastrointestinal Tract, Gastrointestinal Cancer

SpyGlass Surgical Study
Description

* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope * To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study

Conditions

Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease

Virtual Mind-Body Exercises for People Having Pancreatic Surgery
Description

The purpose of this study is to find out if it is practical to provide 2 interventions, VMB exercise classes and EUC (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.

Conditions

Pancreas Disease

SpyGlass™ Discover Percutaneous
Description

To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

Conditions

Pancreatic Diseases, Bile Duct Obstruction, Bile Duct Diseases

Baby Formula and Health
Description

The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.

Conditions

Pancreas Disease

Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Description

Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.

Conditions

Pancreatic Diseases

Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL
Description

Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

Conditions

Cystic Pancreatic Disorders

A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
Description

The following are the study hypothesis: * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. * Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.

Conditions

Pancreatic Disease

Artificial Inteligence in Endoscopic Ultrasound
Description

The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.

Conditions

Pancreatic Cancer, Pancreas Disease, Pancreatic Cyst

Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
Description

The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.

Conditions

Kidney Transplant; Complications, Pancreas Disease

The Effects of the CF Carrier State on the Kidneys and Pancreas
Description

The overarching hypothesis is that CF carriers are at increased risk for developing most of the extrapulmonary conditions associated with CF compared to the general population. Specifically, it is hypothesized that this pilot data will detect subclinical evidence of pancreatic and kidney disorders among CF carriers. This will be determined by bringing CF carriers and controls to the CRU for one visit where they will answer survey questions and undergo laboratory testing. Additionally, they will collect urine and stool samples at home that will be sent to outside laboratories for testing.

Conditions

Carrier State, Pancreatic Disease, Kidney Diseases

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
Description

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Conditions

Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
Description

The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders). 1. To assess the clinical and technical success rates of EUS-Guided interventions 2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses. 3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

Conditions

Therapeutic Endoscopic Ultrasound, Advanced Endoscopy, Therapeutic Endoscopy, Interventional Endoscopy, Interventional Endoscopic Ultrasound, Gastro-Intestinal Disorder, Gastrointestinal Disease, Gastrointestinal Cancer, Gastrointestinal Dysfunction, Gastrointestinal Fistula, Gastrointestinal Infection, Gastrointestinal Injury, Pancreatic Disease, Bile Duct Diseases

Regular vs. Clear Liquid Diet for Mild to Moderate Acute Pancreatitis
Description

Acute pancreatitis is among the most common gastroenterology diagnosis in the United States, and represents a large economic burden to the United States health system. While recent guidelines agree early feeding shortens length of stay, these guidelines fail to provide recommendations on optimal diet to start leaving diet type to clinician discretion. Therefore, the aim is to assess the comparative efficacy of full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP). The study population will target mild to moderate acute pancreatitis patients who can tolerate eating in a single institution. The primary end point will focus on LOHS, and secondary end points will include Pancreatic Activity Scoring System, side effects and readmission.

Conditions

Pancreatitis, Diet, Food, and Nutrition, Diet, Pancreatic Disease, Enteral Nutrition

Intermittent Fasting for Pancreatitis
Description

The purpose of this research is to compare intermittent fasting with a standard diet approach for improving the quality of life related to your pancreas disease. Our hope is to improve your symptoms and prevent you from needing to go into the hospital for pancreas-related issues.

Conditions

Pancreatitis, Pancreatitis, Acute, Pancreatitis, Chronic, Pancreas Disease, Acute Recurrent Pancreatitis

UCSF PANC Cyst Registry
Description

Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management.

Conditions

Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Cancer, Pancreatic Diseases, Pancreatic Intraductal Papillary Mucinous Neoplasm, Intraductal Papillary Mucinous Neoplasm, Pancreatic Ductal Adenocarcinoma, Mucinous Cyst

Comparison of Standard and Endoscope Assisted Endotracheal Intubation
Description

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Conditions

Biliary Tract Diseases, Pancreatic Diseases

Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders
Description

This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.

Conditions

Bile Duct Disorder, Endocrine Pancreas Disorder

Liver, Pancreas and Thyroid Function in Burn Patients
Description

The purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid and the pancreas will be assessed via ultrasound (GE Medical Systems, Waukesha, USA) and standard blood parameters, respectively.

Conditions

Burns, Liver Fibroses, Pancreas Disease, Thyroid Diseases

A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Description

The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.

Conditions

Adenocarcinoma, Pancreatic Neoplasms, Neoplasm, Glandular, Neoplasms, Neoplasms Pancreatic, Digestive System Neoplasm, Endocrine Gland Neoplasms, Digestive System Disease, Pancreatic Diseases, Endocrine System Diseases

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Description

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

Conditions

Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst

Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
Description

This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after having a pancreatectomy.

Conditions

Hyperinsulinism, Diabetes, Pancreatic Diseases, Pancreatectomy; Hyperglycemia

Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Description

The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.

Conditions

Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases