CompletedNot Applicable

PT-GBD to EUS-GBD Conversion Versus Standard Management in High-Risk Acute Cholecystitis Patients

Italy484 participantsStarted 2024-04-01

Plain-language summary

Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. This retrospective multicenter observational study compares long-term outcomes of conversion from PT-GBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) versus standard management in high-risk surgical patients with acute cholecystitis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>18 years * Patients considered unfit for surgery after multidisciplinary discussion * Patients who underwent PT-GBD for acute cholecystitis Exclusion Criteria: * Patients with improved general conditions who become fit for laparoscopic cholecystectomy * Use of anticoagulants that cannot be discontinued * Coagulation and/or platelet hereditary disorders and/or INR \>1.5, PLT \<50,000 * Absolute contraindication for EUS-GBD * Post-surgical altered upper gastrointestinal anatomy * Malignant biliary obstruction

What they're measuring

Recurrent acute cholecystitis

Timeframe: 12-month

Trial details

NCT IDNCT07575360

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Cholecystitis, Acute trials