No registrations found.
ID
Source
Brief title
Health condition
Gallstones
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of stones that have passed spontaneously
Secondary outcome
Time between first and second EUS in patients with stones that have passed spontaneously
Background summary
The clinical relevance of CBD sludge and/or small stones in patients with symptomatic cholecystolithiasis or choledocholithiasis is subject of debate. Although small gallbladder and/or common bile duct stones seem to be associated with an increased risk of biliary pancreatitis, other studies have shown a significant likelihood of spontaneous passage into the bowel without any complications. Smaller stones seem to have a significant chance to pass into the bowel spontaneously. Besides the size of the stone also the time between diagnosis and treatment is described as a factor that might influence the spontaneous passage of gallstones from the CBD.
EUS and ERCP are often planned in the same session, in order to be time efficient. If part of the stones pass spontaneously, this time efficient strategy leads to unnecessarily treated patients. The objectives of this study are 1. to investigate the rate of spontaneous (without ERCP) passing gallstones in patients with CBD stones (≥3mm). 2. to investigate if the rate of spontaneous passing stones is influenced by the time between EUS and ERCP and the size of the diagnosed stone(s). 3. To investigate the clinical relevance of sludge and microlithiasis (<3mm) in the CBD during a watchful wait strategy.
Study objective
About 15% of the patients with gallstones detected by EUS will pass the stones spontaneously into the bowel. This means that in these 15% unnecessary ERCP can be avoided.
Study design
Not applicable
Intervention
Extra second EUS, just before the potentially planned ERCP.
Inclusion criteria
- Patient age ≥ 18 years old.
- Written informed consent.
- Diagnosed with gallstones or sludge based on positive findings at EUS or transabdominal ultrasound.
Exclusion criteria
- Clinical ascending cholangitis
- Severe colic pain
- Any other indication that made the physician decide to perform an ERCP directly at presentation (or at least before the scheduled ERCP).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8751 |
| Other | METC Erasmus MC : MEC-2020-0215 |