ATORVASTATIN for Cholelithiasis (gallstones) following bariatric surgery

Inclusion criteria

• {"criterion_text":"- Scheduled to undergo laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)."}
• {"criterion_text":"- Presence of an intact gallbladder without gallstones, confirmed by preoperative ultrasound."}
• {"criterion_text":"- Preoperative LDL cholesterol level equal to or exceeding 2.0 mmol/L."}

Exclusion criteria

• {"criterion_text":"- Previous bariatric surgery."}
• {"criterion_text":"- Current use of PCSK9 inhibitors, statins, ezetimibe, or fibrates."}
• {"criterion_text":"- Known intolerance to statins."}
• {"criterion_text":"- Presence of symptomatic or asymptomatic gallstones prior to bariatric surgery."}
• {"criterion_text":"- Familial hypercholesterolemia."}
• {"criterion_text":"- Severe liver disease (Child-Pugh score 10–15)."}
• {"criterion_text":"- Severe renal impairment (eGFR < 30 mL/min/1.73 m²)."}
• {"criterion_text":"- Use of CYP3A4 inhibitors due to potential interactions with atorvastatin and increased risk of myopathy."}
• {"criterion_text":"- Use of CYP3A4 inducers, as these may reduce plasma concentrations of atorvastatin and potentially influence the pharmacological effect of the study treatment."}

Primary endpoints

• {"endpoint_text":"- Incidence of gallstone formation six months after bariatric surgery, confirmed by ultrasound examination.","definition_or_measurement_approach":"Confirmed by ultrasound examination six months after bariatric surgery."}

Secondary endpoints

• {"endpoint_text":"- Change in plasma LDL-cholesterol levels between baseline and six months after bariatric surgery.","definition_or_measurement_approach":"Change in plasma LDL-cholesterol measured between baseline and six months post-surgery."}
• {"endpoint_text":"- Change in fecal and plasma bile acid profiles between baseline and six months after bariatric surgery.","definition_or_measurement_approach":"Change in fecal and plasma bile acid profiles measured between baseline and six months post-surgery."}
• {"endpoint_text":"- Incidence and severity of adverse events related to atorvastatin in the post- bariatric population","definition_or_measurement_approach":"Incidence and severity of adverse events related to atorvastatin recorded and assessed in the post-bariatric population (safety monitoring)."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

1

Number Of Sites

1

Number Of Participants

202

Primary sponsor

Full Name

Spaarne Gasthuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands