Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis (EUS-DRAIN)
Cholecystitis, Acute
About this trial
This is an interventional treatment trial for Cholecystitis, Acute focused on measuring Cholecystitis, Non-operable, Endoscopic
Eligibility Criteria
Inclusion Criteria: Patient older than 18 years. Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria. Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index > 5 and/or Karnofsky < 50 or decision of the patient not to have surgery. Signature of the informed consent of the study Exclusion Criteria: Operable acute cholecystitis. Refusal of the patient to participate in the study. Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery. Ascites. Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy. Patients with decompensated cirrhosis, portal hypertension and/or gastric varices Coagulopathy with uncorrectable INR>1.5 or thrombocytopenia <50,000/mm3 uncorrectable. Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia). Hemodynamic instability. Baseline ECOG >=4 Survival expectancy < 6 months
Sites / Locations
- Hospital Universitario de NavarraRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Non-endoscopic treatment group (Group NE)
Endoscopic treatment group (EUS-GBD Group)
Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018, CAL will be classified into three groups according to severity (I,II,III) and empirical antibiotic treatment will be started according to the recommendations of said guideline
The procedure will be performed after at least 6 hours of fasting The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy.