Conservative versus proactive care after EUS-guided gallbladder drainage for acute cholecystitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital General Universitario Dr. Balmis
  Alicante, Alicante, Spain Recruiting
• Hospital Universitario Dr Balmis Alicante
  Alicante, Alicante, Spain Not yet recruiting

Study contacts

• Study coordinator: José Ramón Aparicio Tormo, MD
• Email: japariciot@gmail.com
• Phone: (0034)965933468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.