Cirugia espanola · 2025
One-year outcomes by index treatment in older patients with acute cholecystitis. Protocol of the international, prospective, observational GOLDENEYE study.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Lluís Núria, Pérez-Brotons Sara, de Castro Isabel, Martínez Belén, Aparicio José R, Zapater Pedro, Lluís Fèlix, de-Madaria Enrique
Аннотация
BACKGROUND: This research project is motivated by the increasing prevalence of gallstones and biliary tract diseases in patients of advanced age, while also recognizing that the comorbidity burden of this population may necessitate a tailored treatment approach. Acute cholecystitis can rapidly progress to systemic inflammatory response syndrome, sepsis and even death. Age per se has no bearing on the severity of acute cholecystitis, but the burden of comorbidity in older patients may lead to rapid disease progression.
METHODS: The GOLDENEYE study is an international, multicenter, prospective, observational research project designed to compare the outcomes of different management strategies for acute cholecystitis in seniors. The primary aims are to evaluate the efficacy of different treatments-supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage-on one-year additional treatment modalities, hospital readmissions, and outpatient care. Secondary outcomes are quality of life and survival rates. The study implements propensity score matching analysis to account for the non-randomized allocation of treatment modalities. Patients ≥ 70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, are included. 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 is performed with the REDCap platform for data entry and monitoring.
DISCUSSION: The GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in elderly patients, ultimately improving patient outcomes and healthcare practices in this growing demographic population.
CLINICALTRIALS: gov, NCT07006298.
METHODS: The GOLDENEYE study is an international, multicenter, prospective, observational research project designed to compare the outcomes of different management strategies for acute cholecystitis in seniors. The primary aims are to evaluate the efficacy of different treatments-supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage-on one-year additional treatment modalities, hospital readmissions, and outpatient care. Secondary outcomes are quality of life and survival rates. The study implements propensity score matching analysis to account for the non-randomized allocation of treatment modalities. Patients ≥ 70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, are included. 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 is performed with the REDCap platform for data entry and monitoring.
DISCUSSION: The GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in elderly patients, ultimately improving patient outcomes and healthcare practices in this growing demographic population.
CLINICALTRIALS: gov, NCT07006298.