Een onderzoek naar de veiligheid en mogelijkheden van het plaatsen van een stent in de galblaas tijdens echo-endoscopie bij patiënten met een acute galblaasontsteking die niet in aanmerking komen voor een operatie.
Recruiting
- Conditions
- cholecystitis, EUS-guided drainage, SEMS, stent
- Registration Number
- NL-OMON24539
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Acute cholecystitis, defined according to Tokyo Guidelines:
A. Local signs of inflammation: (1) Murphy’s sign, (2) RUQ mass/pain/tenderness;
Exclusion Criteria
1. Pregnancy;
2. Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Short term major complications, defined as any stent-related life threatening and/or severe event during stent placement or within week (7 days), e.g. bile leakage with development of bile peritonitis, significant bleeding, unscheduled endoscopic/surgical intervention due to adverse event;<br /><br>2. Long term major complications, defined as any stent-related life threatening and/or severe event during occurring later than 1 week (7 days) from stent placement;<br /><br>3. Recurrence of cholecystitis; defined as recurrence of acute cholecystitis according to Tokyo Guidelines after complete clinical response, either before or after stent removal.
- Secondary Outcome Measures
Name Time Method