EUS-guided gallbladder drainage with the AXIOS stent in patients with acute cholecystitis unsuitable for surgery: a feasibility study.

Completed

Conditions: cholecystitis
gallbladder inflammation
10017969
10017998

Registration Number: NL-OMON37861

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Acute cholecystitis, defined according to Tokyo Guidelines:
A. Local signs of inflammation: (1) Murphy*s sign, (2) RUQ mass/pain/tenderness
B. Systemic signs of inflammation: (1) Fever, (2) elevated CRP, (3) elevated WBC count
C. Imaging findings: imaging findings characteristic of acute cholecystitis
Definite diagnosis: (1) One item in A and one item in B are positive
(2) C confirms the diagnosis when acute cholecystitis is suspected
clinically
- Unsuitable for surgery, due to one (or more) of the following items:
A. ASA score > II (ASA = American Society of Anesthesiology)
B. APACHE II score >= 12 (APACHE = Acute Physiology and Chronic Health Evaluation)
C. Onset of symptoms >=7 days before first presentation in hospital
D. Advanced malignancy
E. Unsuitable for surgery upon expert*s opinion for any other reason
- >=18 years
- Eligible for endoscopic intervention
- Written informed consent

Exclusion Criteria

- Pregnancy
- Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,
stomach and duodenum
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation: INR > 1.5 and not correctable and/or platelets < 50.000/mm3
- Previous drainage of the galbladder

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Short term major complications, defined as any stent-related life threatening<br /><br>and/or severe event during stent placement or within week (7 days), e.g. bile<br /><br>leakage with development of bile peritonitis, significant bleeding, unscheduled<br /><br>endoscopic/surgical intervention due to adverse event.<br /><br>- Long term major complications, defined as any stent-related life threatening<br /><br>and/or severe event during occurring later than 1 week (7 days) from stent<br /><br>placement.<br /><br>- Recurrence of cholecystitis; defined as recurrence of acute cholecystitis<br /><br>according to Tokyo Guidelines after complete clinical response, either before<br /><br>or after stent removal. </p><br>

Secondary Outcome Measures