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Study identifier: NCT07006298 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis

Condition: Acute Cholecystitis  ·  Sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante

PhaseN/A
Planned participants376
Who can joinAll sexes, 70 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Nuria Lluis, MD, PhD  ·  +1 (215) 662-4000  ·  nuria.lluis@pennmedicine.upenn.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)Alicante, Alicante, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT07006298