Gallstones

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Gallstones

General Purpose:

The gallbladder is an organ roughly the size and shape of a pear, which is located on the right side of the abdomen, just below the liver. It holds bile, which is a liquid released into the small intestine to help digest dietary fat.

Occasionally, small deposits of bile can harden within the gallbladder, creating what are commonly known as gallstones. They can vary considerably in size, ranging from as small as a grain of sand to as large as a golf ball.

They can occur singularly or in groups. Although some gallstones may cause no symptoms at all, others can be incredibly painful. Symptoms include sudden, intense pain in the upper right abdominal area or just below the breastbone; pain between the shoulder blades; and pain in the right shoulder.

Individuals who have gallstones that are asymptomatic rarely require treatment; only those that lead to the development of symptoms typically require treatment. Complications of gallstones include gallbladder inflammation, blockage of the bile duct (which can lead to jaundice and infection), pancreatitis (inflammation of the pancreas), and cancer of the gallbladder.

No one knows for certain what causes gallstones to develop, but some doctors and researchers think they may occur as a result of too much cholesterol, excess bilirubin (a chemical produced by the liver to help break down red blood cells), or possibly due to inadequate emptying of the gallbladder. Although their exact cause is not known, a number of risk factors for the development of gallstones have been identified.

These include female gender; age 60 or over; American Indian, or Mexican-American heritage; overweight and obesity; pregnancy; diet high in fat and cholesterol, and low in fiber; family history of gallstones; diabetes; history of rapid weight loss; use of certain cholesterol-lowering medications; and hormone replacement therapies.

Gallstone-related research is currently focused on identifying better methods of treatment, more accurate means of diagnosis, and exploring efforts to prevent the development of gallstones.

What Will Gallstone Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for gallstones will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests to look for signs of infection
  • Computed tomography (CT, or “CAT scan”): an imaging procedure that uses an x-ray machine linked to a computer to take detailed pictures of areas inside the body.
  • Hepatobiliary iminodiacetic acid (HIDA) scan: a test that uses a special non-toxic dye which is injected into a vein. The dye then moves through the body and illuminates the areas it passes through to make them more visible when viewed on x-ray. This type of test can help doctors identify potential blockages.
  • Magnetic resonance imaging (MRI): a non-invasive imaging procedure similar to a CT scan that allows doctors to view incredibly detailed, computerized images of areas within the body.
  • Blood tests to look for signs of possible gallstone-related complications, including jaundice, infection, or pancreatitis.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Gallstone Clinical Trial Protocol:

Specific examples of clinical trials for gallstones might include the following:

  • A randomized clinical trial to evaluate the safety and efficacy of a plant-based medicine when used to treat gallstones in individuals age 65 and over. In such a study, half of the patients would be randomly assigned to receive treatment with the medicine while the other half would receive a placebo.
  • An interventional study to determine the safety and efficacy of a new surgical approach to remove the gallbladder in individuals who suffer from severe gallstones. This study would test a surgical procedure never before attempted in humans, during which the gallbladder would be removed through a natural opening (i.e., the mouth, vagina, or rectum) rather than through a surgical incision.
  • An observational study in which individuals with a history of gallstones, and a family history of the condition, provide blood and tissue samples for analysis. The purpose of such a study would be to determine if individuals with a family history share any common genetic mutations that might be associated with an increased risk of gallbladder disease.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the first example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of gallstones (age at onset, size of stones)
  • Any underlying illnesses you have
  • Your family history of gallstones and other gallbladder disease
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for gallstones

Suggested Search Terms:

Once you are ready to begin your search for gallstone clinical trials, the following terms may be of use when combined with “gallstones”: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “elderly,” “side effects,” “medication,” “surgery,” and “diagnosis.”

Current Search Term:

“Gallstones”

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