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Compares treatment options for Acute Cholecystitis
Official title Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)
ClinicalTrials.gov ID: NCT06967597
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Gallbladder drainage by LAMS stent.
- Informed Consent signed
You likely can't join if
- 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
See the full eligibility 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...
- Gallbladder drainage by LAMS stent.
- Informed Consent signed
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Alicante, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Alicante, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.