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Recruiting NCT05702775

Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis

Conditions: Cholecystitis, Acute

Sex: All
Phase: NA
Enrollment: 100
Sponsor: Fundacion Miguel Servet

Location: Spain

Summary

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.

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 studyExclusion 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 varicesCoagulopathy 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 >=4Survival expectancy < 6 months

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702775). StuddyBuddy aggregates publicly available trial information.