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

Launched by HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE · May 3, 2025

Keywords

ClinConnect Summary

The FUGITIVE Trial is a study looking at how to best manage patients with acute cholecystitis, which is inflammation of the gallbladder. This trial focuses on patients who are unable to have surgery due to their health conditions. In the study, participants will be divided into two groups: one group will have a special drain placed in their gallbladder that stays in place indefinitely to help bile flow into the digestive system, while the other group will undergo procedures to remove any stones in the gallbladder over time, eventually allowing for the drain to be removed. The goal is to see which approach leads to fewer complications and better quality of life for patients over the course of a year.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with acute cholecystitis but unfit for surgery due to various health reasons, such as being older than 80 or having serious medical conditions. Participants will need to give their consent to join the study. Throughout the trial, researchers will monitor the patients for any complications, hospital visits, and overall health outcomes to determine the best management strategy for those suffering from this condition.

Gender

ALL

Eligibility criteria

• 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