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Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)

RecruitingNAAges 18 Years - anyAllHospital General Universitario de Alicante
NCT06967597 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients with gallbladder inflammation (acute cholecystitis) who cannot undergo surgery due to their fragility and surgical risk require a gallbladder drainage. It has been confirmed in previous studies that the gallbladder drainage from the digestive tract is a better alternative, because it has fewer complications than external (percutaneous) gallbladder drainage. However, there are no known studies that demonstrate whether it is better to maintain this drainage indefinitely, or to carry out periodic revisions of the drainage to progressively remove the stones lodged in the gallbladder and remove the drainage once this has been achieved. In this study we aim to compare the clinical evolution of patients who undergo this gallbladder drainage, dividing them into two groups: * One group of patients in whom we maintain a metallic prosthesis or stent, which communicates the gallbladder wit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient ≥ 18 years of age * Confirmed acute cholecystitis diagnosed according to Tokyo 2018 criteria. * Patient unfit for surgery: if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) ≥ III, Charlson Comorbidity Index \> 5 and/or Karnofsky \< 50, or patient unwilling to undergo surgery. * Gallbladder drainage by LAMS stent. * Informed Consent signed Exclusion Criteria: * Patient refusal to participate in the study * Gastrointestinal surgically modified anatomy preventing endoscopic access to the gallbladder. * Technical failure to perform endoscopic ultrasound guided-gallbladder drainage. * Moderate or severe ascites. * Severe coagulopathy International Normalized Ratio \>1.5 and/or fibrinogen \<120) or thrombocytopenia (platelets \<20,000). * Patient unable to tolerate sedation or general anesthesia * Haemodynamically unstable patient * Life expectancy \<6 months * Baseline ECOG ≥4 * Patient with ongoing malignancy * Pregnancy * Acute pancreatitis
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What it tests

  • Cholecystoscopy and gallbladder cleaning
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Where

2 sites
Hospital Universitario Dr Balmis Alicante
Alicante, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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