nderstanding the Pathophysiology of metabolic dysfunction-associated steatotic liver disease and Metabolic Syndrome Following Cholecystectomy*

• Conditions: cholecystolithiasis; gallstone disease; 10017628

• Registration Number: NL-OMON56983
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

• Patients referred to a surgeon with abdominal complaints and ultrasound
proven gallstones or sludge (proven before or after referral) subjected to a
laparoscopic cholecystectomy or conservative treatment
• Availability of informed consent.
• Age 30-60 years

Exclusion Criteria

• Patients with pre-operative signs of complicated gallstone disease
(cholecystitis, choledocholithiasis, cholangitis, pancreatitis),
• Signs of cholestasis requiring intervention (e.g. Endoscopisch Retrograde
Cholangio- en Pancreaticografie)
• ASA score III (patient with severe systemic disease (e.g. morbid obesity,
renal failure) or IV (patient with severe systemic disease that is a constant
threat to life)
• Malignancy (excluding skin malignancies: basal cell carcinoma and
non-metastatic squamous cell carcinoma)
• History after bariatric surgery or expected bariatric procedure within 2
years.
• History of inflammatory bowel disease.
• History of alcohol abuse (man >3 and women >2 glasses per day)
• Liver disease (i.e. (autoimmune hepatitis)
• Use steatogenic medication (i.e., methotrexate, tamoxifen, amiodarone, and
systemic corticosteroids)
• Use of DPP4-inhibitors
• Diabetes mellitus
• Use of antibiotics in the previous 3 months
• Gastro-intestinal surgery in the previous 3 months
• Stoma (small bowel or colon)
• Patients that are lactose intolerant / allergic to dairy
• Known anaemia < 6 mmol/l
• Expected short life span of less than 12 months
- Body Mass Index (BMI) >30

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified