One-year outcomes by index treatment in older patients with acute cholecystitis. Protocol of the international, prospective, observational GOLDENEYE study.
Núria Lluís, Sara Pérez-Brotons, Isabel de Castro...
https://pubmed.ncbi.nlm.nih.gov/41448354Actively Recruiting
Age: 70Years +
All Genders
ID07006298
One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
Led by Instituto de Investigación Sanitaria y Biomédica de Alicante · Updated on 2025-06-08
376
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
The GOLDENEYE study is an international and multicenter observational research focused on patients aged 70 years and older diagnosed with acute cholecystitis. It aims to compare outcomes from different management strategies for this condition, recognizing the unique challenges in treating elderly patients with multiple health issues. The study seeks to provide evidence to improve treatment approaches and patient care in this growing elderly population. This study observes various treatment methods including supportive care with antibiotics, early or delayed removal of the gallbladder (cholecystectomy), percutaneous gallbladder drainage, and EUS-guided gallbladder drainage. Instead of assigning treatments randomly, the study uses a method called propensity score matching to fairly compare outcomes among patients receiving these different treatments. Participants will be followed for one year to track additional treatments, hospital readmissions, outpatient visits, quality of life, and survival. Data are collected securely through a dedicated platform across multiple centers. The study emphasizes patient-centered outcomes and aims to provide reliable information to guide future care decisions for elderly patients with acute cholecystitis.
CONDITIONS
Brief Title
One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis
Who Can Participate
Age: 70Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 70 years or older
- Diagnosed with acute cholecystitis according to the Tokyo guidelines
You will not qualify if you...
- Prior episodes of cholecystitis or pancreatitis
- Terminal illness
- Concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 1 year
Participants who undergo routine care for acute cholecystitis are observed for up to one year to assess their outcomes following different treatments such as antibiotics, cholecystectomy, or gallbladder drainage procedures.
Hospital readmissions and outpatient visits as needed over 1 year
Trial Site Locations
Total: 1 location
1
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
Alicante, Alicante, Spain, 03010
Actively Recruiting
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Research Team
N
Nuria Lluis, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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