Actively Recruiting
Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage Multicenter Randomized Clinical Trial: FUGITIVE Trial (FUGITIVE)
Led by Hospital General Universitario de Alicante · Updated on 2025-06-10
82
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two follow-up strategies for patients with acute cholecystitis who cannot undergo surgery due to high risk. The study focuses on patients who receive gallbladder drainage using a lumen-apposing metal stent (LAMS) guided by endoscopic ultrasound (EUS). Researchers want to determine whether maintaining the metal stent indefinitely or performing periodic procedures to remove gallstones and eventually replace the stent leads to better clinical outcomes over one year. Participants will be randomly assigned to one of two groups. One group will have the metal stent left in place indefinitely to ensure continuous bile drainage and prevent new cholecystitis episodes. The other group will undergo elective endoscopic procedures starting one month after drainage to clean the gallbladder, remove stones, and replace the metal stent with a thin plastic catheter. These cleaning procedures may occur weekly until the gallbladder is clear. During the study, participants will have clinical evaluations and lab tests shortly after drainage, followed by scheduled check-ins at 1, 6, 9, and 12 months, either in person or remotely. Researchers will monitor complications, biliopancreatic events, hospital admissions, quality of life, and mortality. The main outcome measured is the rate of biliopancreatic events within a year. The study aims to provide evidence on which management approach results in fewer complications and better patient outcomes.
CONDITIONS
Brief Title
Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Confirmed acute cholecystitis diagnosed according to Tokyo 2018 criteria
- Patient unfit for surgery due to age 80 or older, ASA class III or higher, Charlson Comorbidity Index greater than 5, Karnofsky score less than 50, or unwillingness to undergo surgery
- Gallbladder drainage performed by lumen-apposing metal stent (LAMS)
- Signed informed consent
You will not qualify if you...
- Patient refusal to participate in the study
- Surgically modified gastrointestinal anatomy preventing endoscopic access to the gallbladder
- Technical failure to perform endoscopic ultrasound-guided gallbladder drainage
- Moderate or severe ascites
- Severe coagulopathy (INR greater than 1.5 and/or fibrinogen less than 120) or thrombocytopenia (platelets less than 20,000)
- Unable to tolerate sedation or general anesthesia
- Haemodynamically unstable patient
- Life expectancy less than 6 months
- Baseline ECOG performance status 4 or higher
- Ongoing malignancy
- Pregnancy
- Acute pancreatitis
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (index admission)
Participants undergo endoscopic ultrasound-guided gallbladder drainage using a lumen-apposing metal stent (LAMS) with placement of a coaxial double pigtail plastic stent.
1 procedure visit (in-person)
Duration - Up to 7 days post-procedure or until discharge
Participants receive care in the hospital ward after gallbladder drainage, including clinical evaluation and laboratory tests while admitted.
2 visits (in-person) within 7 days after procedure
Duration - Starting 4 weeks after drainage, weekly procedures until stone clearance
Participants randomized to proactive treatment undergo elective upper gastrointestinal endoscopy for cholecystoscopy, stone removal, and eventual LAMS removal with replacement by a double pigtail plastic stent. Multiple weekly procedures may be required until complete stone clearance.
1 visit at 4 weeks plus weekly visits until complete stone clearance
Duration - Up to 12 months
Participants randomized to conservative management do not have scheduled endoscopic revisions. The LAMS remains in place and is only reviewed if complications arise.
No scheduled visits for endoscopic revision
Duration - 12 months after gallbladder drainage
All participants are followed up periodically to monitor for complications, biliopancreatic events, and overall health status with clinical evaluations and laboratory tests.
Visits or contacts at 1 month, 6 months, 9 months, and 12 months (in-person or telematic)
Trial Site Locations
Total: 2 locations
1
Hospital Universitario Dr Balmis Alicante
Alicante, Alicante, Spain, 03010
Not Yet Recruiting
2
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain, 03015
Actively Recruiting
Research Team
J
José Ramón Aparicio Tormo, MD
P
Pedro López-Muñoz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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