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A study to evaluate if atorvastatin prevents gallstones in patients undergoing bariatric surgery

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What is this study about?

This study focuses on the prevention of gallstones, which are hard deposits that can form in the gallbladder, in people who have undergone bariatric surgery, a procedure used for significant weight loss. The purpose of the study is to evaluate whether the medication atorvastatin can help prevent these stones from forming. This medication is an oral drug used to lower cholesterol, a fatty substance found in the blood.

Participants in the study will receive either atorvastatin or standard care. If atorvastatin is used, it is taken once daily, starting two weeks before the surgery and continuing for six months afterward. The study will monitor changes in LDL-cholesterol, which is often referred to as bad cholesterol, as well as levels of bile acids, which are substances produced by the liver to help digest fats. The process includes monitoring for any side effects related to the medication during the period following the surgery.

Who Can Join the Study?

  • You must be scheduled for a weight loss surgery, specifically a laparoscopic Roux-en-Y gastric bypass (a procedure where part of the stomach is bypassed) or a sleeve gastrectomy (a procedure where a large part of the stomach is removed to limit food intake).
  • Laparoscopic means the surgery is performed using small incisions and a tiny camera.
  • You must have a gallbladder, which is a small organ under the liver that stores bile, that is currently healthy and has no gallstones (hardened deposits of digestive fluid).
  • A doctor must confirm your gallbladder is healthy using an ultrasound, which is a test that uses sound waves to create images of the inside of your body.
  • Your LDL cholesterol level, often called “bad cholesterol,” must be 2.0 mmol/L or higher.
  • mmol/L is a unit used to measure the amount of a substance, such as cholesterol, in your blood.

Who Cannot Join the Study?

  • You have had bariatric surgery (weight loss surgery) in the past.
  • You are currently taking PCSK9 inhibitors, statins, ezetimibe, or fibrates, which are different types of medications used to manage cholesterol.
  • You are known to be intolerant to statins, meaning your body has a bad reaction to this specific type of cholesterol medication.
  • You already have gallstones (small, hard deposits in your gallbladder), whether they are causing you pain or not, before your planned surgery.
  • You have familial hypercholesterolemia, which is an inherited condition that causes very high cholesterol levels from birth.
  • You have severe liver disease, measured by a specific scale called the Child-Pugh score (a tool doctors use to determine how well the liver is functioning).
  • You have severe renal impairment, which means your kidneys are not working well enough to filter your blood properly, measured by a value called eGFR.
  • You are taking CYP3A4 inhibitors, which are medicines that can interfere with how the study drug works and increase the risk of myopathy (a condition causing muscle weakness or pain).
  • You are taking CYP3A4 inducers, which are medicines that can lower the amount of the study drug in your blood, making it less effective.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Spaarne Gasthuis Hoofddorp The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.03.2026

Trial locations

Investigated drugs:

Atorvastatin is a medication used to lower cholesterol levels in the blood. In this study, it is being tested to see if taking it before and after weight loss surgery can help prevent the development of gallstones.

Cholelithiasis – This condition occurs when hard deposits, known as stones, form inside the gallbladder. These stones are typically made of hardened digestive fluids like cholesterol or bile. The process often develops when the gallbladder does not empty correctly or when there is too much cholesterol in the bile. Over time, these deposits can grow in size or number. The formation can be triggered by various factors, including rapid changes in body weight.

Trial ID:
2025-524191-38-00
Protocol code:
CHOLSTONE
Trial Phase:
Therapeutic confirmatory (Phase III)

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