In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs.
The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC.
Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.
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
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.
Parallel
Endoscopic treatment group (EUS-GBD group
Procedure/SurgeryThe placement of a endoscopic drain 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. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out.
Cumulative rate of biliopancreatic events development at one year of follow-up
Biliopancreatic event (BPE): event related to biliary pathology such as acute cholecystitis, acute cholangitis, symptomatic choledocholithiasis, acute pancreatitis mild-moderate, severe acute pancreatitis, biliary colic (complicated or uncomplicated), liver abscess
Proportion of technical success of EUS-GBD and the complications
Describe the proportion of technical success of EUS-GBD and the complications associated with the management of the patients included in the study
Evaluate healing and time to healing of acute cholecystitis
Evaluate healing and time to healing of acute cholecystitis
Evaluate the duration of the index admission
Evaluate the duration of the index admission
Evaluate the duration of antibiotic treatment
Evaluate the duration of antibiotic treatment
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