Pancreatic & Biliary Diseases Clinical Trials

The gastrointestinal specialists and researchers at Cedars-Sinai are deeply committed to improving the diagnostic and treatment options available for diseases of the pancreas and liver. As a patient, you'll have the opportunity to participate in clinical trials as part of our efforts to discover and invent effective new therapies for a wide range of conditions, including cancers of the pancreas and bile duct, acute and chronic pancreatitis, gallstones and other disorders.

Questions? See the Clinical Trials FAQs.


Click below to view clinical trials by areas:

Biliary Disease

Condition:

Biliary disease, pancreas disease, interventional endoscopy

Key Inclusion Criteria

  • Pediatric patients who are less than 18 years old and identified as needing ERCP

Summary:

This study focuses on pediatric patients who have been identified as needing an endoscopic procedure called endoscopic retrograde cholangiopancreatography (ERCP). The purpose of the study is to gain knowledge about ERCP, which is used to diagnose and treat problems in the bile and pancreas. During this procedure, a narrow, flexible tube (endoscope) that has a video camera is utilized. Participants will be asked for permission to review medical records; additional procedures or clinic visits are not required to take part in the study. Researchers aim to learn more about the indications and safety of ERCP in pediatric patients to improve treatment and create specific guidelines for using this procedure in children.

Condition:

Diagnostic, biliary hilar obstruction, percutaneous transhepatic biliary drainage, endoscopic retrograde cholangiopancreatography

Key Inclusion Criteria

  • Patient with cholestasis (decrease in bile flow) due to suspected malignant hilar obstruction (tumors)
  • Over 40 years old
  • Evidence of a biliary hilar stricture (narrowing of bile duct) or intrahepatic but no extrahepatic biliary ductal dilation (duct dilation within the liver but not outside the liver)

Summary:

A Multicenter, Randomized Trial of Percutaneous Transhepatic Biliary Drainage Versus Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction (IRB no. 50643)

Condition:

Primary biliary cholangitis

Key Inclusion Criteria

  • 18-75 years old
  • Primary biliary cholangitis by at least two of the following criteria:
    • History of alkaline phosphatase above upper limit of normal (ULN) for at least 6 months
    • Positive anti-mitochondrial antibodies titers
    • Documented liver biopsy result consistent with primary biliary cholangitis (with no cirrhosis)

Summary

The purpose of this study is to evaluate whether an investigational drug called EDP-305 is safe and effective for individuals with primary biliary cholangitis (PBC), a chronic disease of the liver, in patients with or without an inadequate response to ursodiol therapy. Researchers also aim to determine the dose of study drug that works best. The study will compare the effects of EDP-305 against the effects of a placebo (inactive substance). Samples for biomarkers will also be collected. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Biomarkers can be helpful in evaluating the effectiveness and safety of a medicine. Participants will be randomly assigned to receive EDP-305 or placebo.

Gastrointestinal Mucosal

Condition:

Gastrointestinal mucosal/submucosal disease

Key Inclusion Criteria:

  • At least 18 years old
  • Scheduled to undergo ESD as part of standard-of-care treatment

Summary:

This study focuses on individuals who have a mass or nodule anywhere in the esophagus, stomach or intestines and who have been scheduled for an endoscopic submucosal dissection (ESD) procedure. The purpose of the study is to collect clinical information about individuals who undergo ESD at Cedars-Sinai. ESD is an advanced endoscopic procedure used to treat abnormalities on the wall of the gastrointestinal tract (esophagus, stomach or intestine).

By using ESD, the need for open surgery is avoided, and large areas of affected tissue can be removed in one piece while protecting the healthy areas. Researchers believe it is important to obtain information on how patients respond to ESD treatment so that it can be used in large patient populations who need endoscopic treatment for gastrointestinal abnormalities.

Interventional Endoscopy

Condition:

Biliary disease, pancreas disease, interventional endoscopy

Key Inclusion Criteria

  • Pediatric patients who are less than 18 years old and identified as needing ERCP

Summary:

This study focuses on pediatric patients who have been identified as needing an endoscopic procedure called endoscopic retrograde cholangiopancreatography (ERCP). The purpose of the study is to gain knowledge about ERCP, which is used to diagnose and treat problems in the bile and pancreas. During this procedure, a narrow, flexible tube (endoscope) that has a video camera is utilized. Participants will be asked for permission to review medical records; additional procedures or clinic visits are not required to take part in the study. Researchers aim to learn more about the indications and safety of ERCP in pediatric patients to improve treatment and create specific guidelines for using this procedure in children.

Pancreatic cancer

Condition:

Diabetes, pancreatic cancer, pancreatic diseases

Key Inclusion Criteria:

  • At least 40 years old; less than 85 years old
  • Must have a diagnosis of one of the following:
    • New onset diabetes in subjects with pancreatic cancer (PDAC)
    • New onset diabetes in subjects with chronic pancreatitis
    • New onset diabetes in subjects without pancreatic disease 
    • Long-standing Type 2 diabetes without pancreatic disease
    • Long-standing diabetes in subjects with PDAC
    • Long-standing diabetes subjects with chronic pancreatitis
    • Non-diabetic subjects with PDAC
    • Non-diabetic subjects with chronic pancreatitis
    • Non-diabetic control subjects without pancreatic disease

Summary:

This study focuses on patients who have chronic pancreatitis, pancreatic cancer, or no known pancreas disease. It is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis (when the pancreas is swollen and irritated all the time and affected by scarring) or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The purpose of this study is to develop a blood test to distinguish various causes of diabetes. To this end, researchers will enroll a range of patients; most have developed diabetes within the last 3 years, but the study will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. Participants will be asked to complete a questionnaire regarding their personal and family history, and a series of blood samples will be collected prior to and for 2 hours following consumption of a liquid nutritional supplement called Boost. 

Condition:

Pancreatic adenocarcinoma

Key Inclusion Criteria

  • At least 18 years old
  • Confirmed locally advanced pancreatic adenocarcinoma
  • Has at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm within 6 weeks of screening

Summary:

This study focuses on patients who have pancreatic cancer that cannot be removed with surgery and who have already received standard of care treatment (including IV chemotherapy). The purpose of the study is to determine whether the use of an investigational drug called NanoPac helps kill cancer cells in patients with pancreatic cancer. Researchers also aim to identify the dose of NanoPac that is best tolerated and causes the least side effects when injected directly into the tumor in the pancreas.

NanoPac is made of very small particles of another drug called paclitaxel, which is a chemotherapy drug approved by the U.S. Food and Drug Administration for other types of cancer. The use of Nanopac in this study is investigational.

Pancreatic diseases

Condition:

Diabetes, pancreatic cancer, pancreatic diseases

Key Inclusion Criteria:

  • At least 40 years old; less than 85 years old
  • Must have a diagnosis of one of the following:
    • New onset diabetes in subjects with pancreatic cancer (PDAC)
    • New onset diabetes in subjects with chronic pancreatitis
    • New onset diabetes in subjects without pancreatic disease 
    • Long-standing Type 2 diabetes without pancreatic disease
    • Long-standing diabetes in subjects with PDAC
    • Long-standing diabetes subjects with chronic pancreatitis
    • Non-diabetic subjects with PDAC
    • Non-diabetic subjects with chronic pancreatitis
    • Non-diabetic control subjects without pancreatic disease

Summary:

This study focuses on patients who have chronic pancreatitis, pancreatic cancer, or no known pancreas disease. It is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis (when the pancreas is swollen and irritated all the time and affected by scarring) or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The purpose of this study is to develop a blood test to distinguish various causes of diabetes. To this end, researchers will enroll a range of patients; most have developed diabetes within the last 3 years, but the study will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. Participants will be asked to complete a questionnaire regarding their personal and family history, and a series of blood samples will be collected prior to and for 2 hours following consumption of a liquid nutritional supplement called Boost. 

Condition:

Pancreatic diseases

Key Inclusion Criteria

  • Patient who is or will be scheduled for a blood draw, tissue biopsy, and/or biofluid collection at Cedars-Sinai for clinical diagnostic purposes and
  • Adult patient with pancreatic disease seen at Cedars-Sinai under the care of a Panc-Bank study investigator who is the patient's treating physician

Summary:

The purpose of the Pancreatic Biomarker Bank ("Panc-Bank") is to identify biomarkers that influence an individual's risk of developing pancreatic diseases. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Through the Panc-Bank, researchers also aim to discover new tests and treatments for pancreatic diseases, as well as further their understanding of these diseases.

The Panc Bank will collect patients' blood, tissue, and biofluid samples to be used for future research; these materials will be studied together with clinical information from medical records.

Condition:

Pancreatitis

Key Inclusion Criteria

  • Must be between 18-75 years old at the time of enrollment

GREEN GROUP I: No Pancreas Disease Controls

  • No personal history or symptoms of pancreatic disease

GREEN GROUP II: Chronic Upper Abdominal Pain of Suspected Pancreatic Origin

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP I: Indeterminate Chronic Pancreatitis (CP) with no history of Acute Pancreatitis

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP II: Acute Pancreatitis (AP)

  • History of 1 documented attack of AP in the preceding 18 months

YELLOW GROUP III: Recurrent Acute Pancreatitis (RAP)

  • 2 or more documented attacks of AP separated by at least 1 month

RED GROUP: Definite Chronic Pancreatitis

  • Presence of unequivocal (definite) CP and/or parenchymal and/or ductal calcifications 

Summary:

The purpose of this study is to learn about chronic pancreatitis and discover new ways to detect, treat and help prevent the disease. The study aims to determine how the diagnosis can be made earlier, why and how the disease progresses, and what genetic factors may affect the chances of developing chronic pancreatitis. Researchers also aim to learn about the natural history of chronic pancreatitis (what happens over a long period of time).

Chronic pancreatitis occurs when the pancreas is affected by inflammation and scarring. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage pancreatitis and its associated complications. This study aims to provide the most accurate and reliable estimates to date on disease progression and clinical events involving chronic pancreatitis. Participants will be asked to complete questionnaires and provide specimen samples, among other study procedures. Additionally, the participant’s physician and research coordinator will complete a case report form about the participant’s pancreatic history, symptoms and treatment.