cholecystitis, EUS-guided drainage, SEMS, stent
Conditions
Interventions
EUS-guided transgastric or transduodenal gallbladder drainage with placement of an AXIOS stent.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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; 2. 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. 3. ≥18 years; 4. Eligible for endoscopic intervention; 5. Written informed consent.
Exclusion criteria
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; 3. Patients unwilling to undergo follow-up assessments; 4. Patients diagnosed with pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal); 5. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum; 6. Patients with liver cirrhosis, portal hypertension and/or gastric varices; 7. Abnormal coagulation: INR > 1.5 and not correctable and/or platelets < 50.000/mm3; 8. Previous drainage of the galbladder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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; 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
| Measure | Time frame |
|---|---|
| 1. Technical success of stent placement; defined as transmural passage of the stent across the stomach or duodenum into the gallbladder; 2. 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; 3. Total procedure time; time between first entry of and last withdrawal from the mouth; 4. Technical success of stent removal; defined as removal of the stent in a single session without complications; 5. Stent patency at stent removal; defined as a patent stent opening assessed during upper endoscopy; 6. 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); 7. Gallbladder characteristics including the presence of gallstones at 12 months after initial stent placement. | — |
Contacts
Public ContactD. Walter
P.O. Box 85500
Outcome results
None listed