Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting: Utility and Diagnostic Accuracy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Gallbladder pathology (yes / no)
Study Overview
Brief Summary
Every year, many patients undergo weight-loss (bariatric) surgery. While this surgery leads to significant and intended weight loss, it also increases the risk of developing gallstones or other gallbladder problems.
Approximately one in five patients later requires a second operation to remove the gallbladder. This type of surgery carries a higher risk of complications and reoperations compared with gallbladder surgery performed in the general population.
Preventive treatment may help reduce this risk. One option is medical treatment with Ursochol, which has been shown to lower the risk of developing gallstones after bariatric surgery. However, this treatment is only effective in patients who have not already developed gallstones before surgery.
This means patients need a reliable preoperative ultrasound examination of the gallbladder. Unfortunately, performing ultrasound can be technically challenging in patients with obesity, making it harder to detect small stones or other abnormalities.
The goal is therefore to improve the examination of the gallbladder in patients undergoing bariatric surgery in order to better identify who may benefit from preventive treatment.
The study
The investigators are comparing two types of ultrasound examination of the gallbladder:
- Standard ultrasound performed on the outside of the abdomen using a handheld probe.
- Laparoscopic ultrasound performed during bariatric surgery using a small ultrasound probe placed inside the abdomen, typically placed on the liver near the gallbladder.
It is of interest to find out whether the ultrasound performed during surgery finds more:
- Gallstones
- Sludge
- Small stones (microlithiasis)
- Thickening of the gallbladder wall
By improving detection, the investigators aim to better guide preventive treatment and reduce the need for future gallbladder surgery.
Detailed Description
- TITLE Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting
- BACKGROUND AND RATIONALE
2.1 Clinical Background Bariatric surgery is an established and effective treatment for severe obesity. In Denmark, approximately 2,000 bariatric procedures are performed annually. These procedures result in significant and intended weight loss and improvement in metabolic comorbidities. However, rapid weight loss is associated with an increased risk of gallstone formation.
Gallstone disease is one of the most common postoperative complications following bariatric surgery. Approximately 10% of patients undergo cholecystectomy within two years after surgery, increasing to up to 20% within ten years. Importantly, cholecystectomy in patients who previously underwent bariatric surgery is associated with:
• Increased risk of surgical complications
• Higher rates of reoperation
- More technically complex procedures
- Increased risk of bile duct injury In patients with Roux-en-Y gastric bypass, management of biliary tract disease is particularly challenging due to altered gastrointestinal anatomy, which complicates endoscopic access (e.g., ERCP).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥18 years
- •Scheduled for bariatric surgery
- •Able to provide informed consent
Exclusion Criteria
- •Previous cholecystectomy
- •Previous biliary surgery
- •Previous liver surgery
- •Inability to provide informed consent
Arms & Interventions
Ultrasound examination
Intervention: Diagnostic procedures (Diagnostic Test)
Outcomes
Primary Outcomes
Gallbladder pathology (yes / no)
Time Frame: From preoperative ultrasound (within 31 days before surgery) to laparoscopic ultrasound during bariatric surgery
Composite endpoint consisting of gallstones (yes/no), slugde (yes/no), micro- lithiasis (yes/no), diffuse gallbladder wall thickness over 3 mm (yes/no).
Secondary Outcomes
- Interobserver variability(From preoperative ultrasound (within 31 days before surgery) to laparoscopic ultrasound during bariatric surgery)
Investigators
Benjamin Drejer Petersen
Principal Investigator
Esbjerg Hospital - University Hospital of Southern Denmark