Gastroenterology and Hepatology Research Studies

The OHSU Division of Gastroenterology and Hepatology's Research Team provides expertise in clinical research. We conduct research studies for various gastrointestinal and hepatic conditions. Most trials have a limited number of spots or time allowed to enroll patients.

Currently Enrolling Trials

Abdominal Wall Injections for Abdominal Pain

Title: Effect of Abdominal Wall Injections on Abdominal Pain

Goal: The goal of the study is to determine the effect of abdominal wall injections on abdominal pain.

Who is Eligible: Patients with abdominal wall pain receiving an injection of lidocaine for abdominal wall pain.

Principal Investigator: Sophia Lichenstein-Hill, DNP

Website: https://clinicaltrials.gov/study/NCT06121466

Title: Dissecting Immune Mechanisms of Colitis and Hepatitis that Occurs in Patients on Immune Checkpoint Inhibitor Therapy (anti-PD-1, anti-PD-L1, and/or anti CTLA-4) for Cancer

Goal: The goal of this research is to understand the basic immune mechanisms that cause inflammatory colitis and hepatitis associated with immune checkpoint inhibitors and the factors that predict which patients are likely to develop these immune toxicities.

Who is Eligible: Patients aged 18-80 who are on checkpoint inhibitors or are about to start them.

Principal Investigator: Molly Thomas, MD, PhD

Website: https://www.ohsu.edu/school-of-medicine/thomas-lab/projects

GLNE

Study Title: Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Goal: The goal of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy.

Who is Eligible: Patients scheduled for a colonoscopy for colon cancer surveillance, or patients with colon cancer who have not yet had surgery, chemotherapy or radiation.

Principal Investigator: Seth Crockett, MD, MPH

Website: https://classic.clinicaltrials.gov/ct2/show/NCT00843375

FORTE

Study Title: Five or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Goal: The goal of this study is to determine the appropriate surveillance for patients who have 1-2 small benign polyps (adenomatous polyps/adenomas) removed during colonoscopy.

Who is Eligible: Patients ages 50-70, with a first-time diagnosis of 1-2 non-advanced polyps removed by colonoscopy.

Principal Investigator: Seth Crockett, MD, MPH

Website: https://www.nrgoncology.org/FORTE

COOP

Study Title: Colonoscopy versus Stool-based Testing for Older Adults with a History of Colon Polyps

Goal: The goal of this study is to compare the effectiveness of annual fecal immunochemical testing (FIT) vs colonoscopy in adults ages 65-82 with history of low-risk colorectal polyps.

Who is Eligible: Patients ages 65-82, with 1-2 non-advanced polyps on their most recent colonoscopy.

Principal Investigator: Seth Crockett, MD, MPH

Website: https://www.pcori.org/research-results/2021/comparing-two-ways-monitor-colon-cancer-older-adults-history-colon-polyps-coop-study

EsoGuard

Title: A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma

Goal: The purpose of this study is to compare the results of a new investigational procedure to the currently accepted procedure for diagnosing Barrett’s Esophagus and esophageal adenocarcinoma. The new procedure being tested uses the EsoCheck™ device to obtain cells from the esophagus. The cells are then assessed with the EsoGuard lab test.

Who is Eligible: Men aged 50 years and above with ≥ 5 years of either gastroesophageal reflux disease (GERD) symptoms or GERD treated with proton pump inhibitor (PPI)
therapy.

Principal Investigator: Fouad Otaki, MD

Website: https://classic.clinicaltrials.gov/ct2/show/NCT04293458

BEST-RRP

Title: Screening for Esophageal Cancer in Rural Oregon without Endoscopy

Goal: This is a proof-of-concept study to pilot the use of an FDA-approved swallowable esophageal cell-collection device (SECD) to screen for esophageal cancer in 2-3 rural primary care clinics in Oregon. 

Who is Eligible: Patients living in a rural area with a diagnosis of chronic GERD and 3 or more of the following risk factors: (1) male, age > 50 years, (2) white race, (3) tobacco smoking, (4) obesity, (5) family history of Barrett's Esophagus or esophageal cancer in a first-degree relative.

Principal Investigator: Fouad Otaki, MD

Website: 

PATENT-E

Title: Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture - Esophagus

Goal: This study is being conducted to see whether GIE Medical’s new ProTractX3™ TTS drug coated balloon can treat esophageal strictures and reduce the rate of recurrence.

Who is Eligible: Patients with a diagnosis of a benign esophageal stricture with at least 2 previous dilations, at least one of which occurred in the last 12 months and achieved a diameter of 15mm.

Principal Investigator: Fouad Otaki, MD

Website: https://clinicaltrials.gov/study/NCT05561114

FMT National Registry

Title: Fecal Microbiota Transplant National Registry

Goal: The goal of the research is to understand the safety and effectiveness of fecal microbiota transplant as a treatment for C. diff and other health conditions, as well as its impact on patients over the years.

Who is Eligible: Patients receiving FMT or other gut-related-microbiota products.

Principal Investigator: Melissa Hershman, MD, BSN

Website: https://clinicaltrials.gov/study/NCT03325855

cfRNA as a Biomarker for Hepatocellular Carcinoma

Title: Study of cell-free RNA as a Biomarker for Hepatocellular Carcinoma (HCC)

Goal: The goal of this study is to identify genetic biomarkers of liver cirrhosis and hepatocellular carcinoma, and identify whether they predict response to treatment.

Who is Eligible: Patients age 18-100 are eligible for this study. Patients must fit into one of three categories: (1) have no underlying liver disease or cancer, (2) have  cirrhosis or (3) have hepatocellular carcinoma.

Principal Investigator: Scott Naugler, MD

SHARP

Title: Sphincterotomy for Acute Recurrent Pancreatitis

Goal: The goal of the study is to determine if the endoscopic retrograde cholangiopancreatography (ERCP) procedure benefits patients with recurrent acute pancreatitis and pancreas divisum.

Who is Eligible: Patients with pancreas divisum that have had at least two attacks of pancreatitis, at least one of which was in the past year.

Principal Investigator: Gregory Cote, MD, MS

Website: https://www.pancreasdivisum.com/

EA2185

Study Title: Comparing Two Methods to Follow Patients with Pancreatic Cysts

Goal: The goal of this study is to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcomes for patients with pancreatic cysts.

Who is Eligible: Patients ages 50-75 with a pancreatic cyst ≥ 1 cm with imaging (CT, MRI, or EUS) in the past 6 months. 

Principal Investigator: Kaveh Sharzehi, MD, MS

Website: https://ecog-acrin.org/clinical-trials/ea2185-pancreas-cancer-preventio…

PCDC

Title: Validation of Novel Imaging and Molecular Tests for Early Detection of Pancreatic Cancer through Risk-stratified Community Engagement Programs

Goal: The goal of this study is to evaluate the dynamics of blood and imaging biomarkers for pancreatic cancer in high-risk patients

Who is Eligible: Patients undergoing MRI/MRCP for either (1) a known diagnosis of chronic pancreatitis, (2) abdominal pain without a known history of pancreatitis, but with a concomitant diagnosis of diabetes, (3) patients with a suspected diagnosis of intraductal papillary mucinous neoplasms (IPMN), and (4) patients with a known or suspected diagnosis of pancreatic ductal adenocarcinoma (PDAC). Healthy volunteers will also be recruited as a comparison group. 

Principal Investigator: Gregory Cote, MD, MS