cholecystitis gallbladder inflammation
Conditions
Interventions
EUS-guided transgastric or transduodenal gallbladder drainage with placement of
an AXIOS stent (Xlumena Inc., Mountain View, California USA). No comparator is
used.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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. - 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. - Recurrence of cholecystitis; defined as recurrence of acute cholecystitis according to Tokyo Guidelines after complete clinical response, either before or after stent removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Technical success of stent placement; defined as transmural passage of the stent across the stomach or duodenum into the gallbladder. - Functional success of stent placement; defined as normalization of clinical parameters of acute cholecystitis within 96 hours. Clinical parameters reported are abdominal pain evaluated by the patients on a 10-point visual analogue scale, temperature, white blood cell count and serum C-reactive protein concentration. - Total procedure time; time between first entry of and last withdrawal from the mouth. - Technical success of stent removal; defined as removal of the stent in a single session without complications. - Stent patency at stent removal; defined as a patent stent opening assessed during upper endoscopy. - Stent migration at stent removal: defined as any migration of the AXIOS stent into the gallbladder (distal migration) or the stomach or duodenum (proximal migration). - Gallbladder characteristics including the presence of gallstones at 12 months after initial stent placement. | — |
Countries
Netherlands
Outcome results
None listed