Background: The GOLDENEYE study is an international, multicenter, prospective observational investigation designed to compare the outcomes of various management strategies for acute cholecystitis in patients aged 70 years and older. This research is driven by the increasing prevalence of gallstones and biliary tract diseases in the elderly, alongside a recognition that the burden of comorbidity in this population may necessitate tailored treatment approaches to optimize outcomes. Patients and Methods: The primary aims of the study are to evaluate the efficacy of different treatments -supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage- on patient-centric outcomes, including one-year additional treatment modalities, hospital readmissions, outpatient encounters, quality of life, and survival rates. The study adopts a robust design incorporating propensity score matching analysis to account for the non-randomized allocation of treatment modalities, thereby minimizing selection bias and enhancing the comparability of treatment groups. Inclusion criteria are centered on patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, while key exclusion criteria include prior episodes of cholecystitis or pancreatitis, terminal illness, and concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy. Data collection will leverage the REDCap platform for systematic and secure data management, facilitating real-time data entry and monitoring across participating centers. Discussion: This comprehensive approach ensures the integrity and reliability of data collected on demographics, gender, clinical outcomes, and quality of life measures. Through its innovative design and methodology, the GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in the elderly, ultimately improving patient outcomes and healthcare practices in this growing demographic population.
Study Type
OBSERVATIONAL
Enrollment
376
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
Alicante, Alicante, Spain
RECRUITING1 year additional procedures, hospital readmissions or outpatient visits
Percentage of patients requiring any additional procedure, hospital readmission or outpatient visit during the first year.
Time frame: 1 year
1-year health-related quality of life
The EQ-5D-5L questionnaire is used to assess quality of life in elderly individuals. It encompasses five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated across five severity levels. Level 1 indicates that the patient has no problems. Level 5 indicates the worst condition. Additionally, the questionnaire has a scale. This scale is numbered from 0 to 100. A score of 100 indicates the best health possible. Zero means the worst health possible. Measurements will be obtained during the initial admission and at one, three, and twelve months.
Time frame: 1 year
1-year overall survival
Survival will be defined as the time elapsed between the date of index admission and the date of death or last follow-up. Survival curves will be constructed by the Kaplan-Meier method and compared using the log-rank test. A multivariable Cox proportional hazards regression model will be used to identify prognostic factors associated with survival. All variables that are significant at 0.10 in the univariable analysis will be entered into a multivariable model. P-values less than 0.05 will be considered statistically significant. All analyses will be performed with RStudio, version 1.2.5001 (Integrated Development for R. RStudio, Inc., Boston, MA, USA).
Time frame: 1 year
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