Conservative versus proactive care after EUS-guided gallbladder drainage for acute cholecystitis
Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage. Multicenter Randomized Clinical Trial: FUGITIVE Trial (FUGITIVE)
This trial will test whether, for people with acute cholecystitis who cannot have surgery, keeping the endoscopic gallbladder stent in place long-term or doing regular endoscopic cleanings and removing the stent works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital General Universitario de Alicante Academic / other |
| Locations | 2 sites (Alicante, Alicante and 1 other locations) |
| Trial ID | NCT06967597 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls adults with acute cholecystitis who are unfit for surgery and have undergone EUS-guided transmural gallbladder drainage with a lumen-apposing metal stent (LAMS). Participants are assigned to conservative management with indefinite retention of the LAMS or to a proactive strategy involving scheduled endoscopic cholecystoscopy, gallstone removal, and stent revision or removal. Outcomes include recurrent cholecystitis, procedure-related complications, need for additional drainage or surgery, and stent-related adverse events over planned follow-up. The trial procedures are performed at a single center by experienced endoscopists using standard endoscopic techniques.
Who should consider this trial
Good fit: Adults (≥18) with confirmed acute cholecystitis per Tokyo 2018 who are unfit for cholecystectomy (for example age ≥80, ASA ≥III, high comorbidity burden, or low functional status) and who have received EUS-GBD with a LAMS are ideal candidates.
Not a fit: Patients who are suitable candidates for standard cholecystectomy, those with altered gastrointestinal anatomy preventing endoscopic access, severe coagulopathy, very short life expectancy, or inability to tolerate sedation are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify the safer, more effective follow-up approach to prevent recurrent gallbladder infections and reduce stent-related complications in patients who cannot have surgery.
How similar studies have performed: Previous studies suggest EUS-guided gallbladder drainage can have fewer complications than percutaneous drainage, but evidence is limited and conflicting about the best long-term management of LAMS.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alicante, Alicante and 1 other locations
- Hospital Universitario Dr Balmis Alicante — Alicante, Alicante, Spain (Not_yet_recruiting)
- Hospital General Universitario Dr. Balmis — Alicante, Alicante, Spain (Recruiting)
Study contacts
- Study coordinator: José Ramón Aparicio Tormo, MD
- Email: japariciot@gmail.com
- Phone: (0034)965933468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.