Transabdominal and Laparoscopic Ultrasound in a Bariatric Setting

NCT07453186 | Recruiting

• 1 other identifier: EsbjergH
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstone Disease; Bariatric Patients Undergoing Bariatric Surgery; Ultrasonic Diagnosis

Keywords

Bariatric surgery; Gallstone disease; Metabolic surgery; Biliary disease; Ultrasound; Laparoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Gallbladder pathology (yes / no)

  Composite endpoint consisting of gallstones (yes/no), slugde (yes/no), micro- lithiasis (yes/no), diffuse gallbladder wall thickness over 3 mm (yes/no).

  From preoperative ultrasound (within 31 days before surgery) to laparoscopic ultrasound during bariatric surgery

Secondary Outcomes (1)

• Interobserver variability

  From preoperative ultrasound (within 31 days before surgery) to laparoscopic ultrasound during bariatric surgery

Study Arms (1)

Ultrasound examination

OTHER

Diagnostic Test: Diagnostic procedures

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

In the same patients, we will do both transabdominal and laparoscopic ultrasound

Also known as: Transabdominal ultrasound, Laparoscopic ultrasound

Ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Scheduled for bariatric surgery
• Able to provide informed consent

You may not qualify if:

• Previous cholecystectomy
• Previous biliary surgery
• Previous liver surgery
• Inability to provide informed consent

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Esbjerg og Grindsted Sygehus

Esbjerg, 6700, Denmark

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Gallbladder Diseases

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Central Study Contacts

Benjamin Petersen, M.D.

CONTACT

+45 79 18 57 14; benjamin.drejer.petersen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective observational diagnostic accuracy study with paired design.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)