Status:
RECRUITING
Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)
Lead Sponsor:
Hospital General Universitario de Alicante
Conditions:
Acute Cholecystitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 studi...
Detailed Description
Laparoscopic cholecystectomy is the gold standard for treating acute cholecystitis (AC). However, not all patients are suitable candidates for surgery during an AC episode. After recovery, some may im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06967597
Start Date
June 1 2025
End Date
June 1 2027
Last Update
June 10 2025
Active Locations (2)
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1
Hospital Universitario Dr Balmis Alicante
Alicante, Alicante, Spain, 03010
2
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain, 03015