One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Cholecystitis. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
Overview
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.
Primary outcome measures
- 1 year additional procedures, hospital readmissions or outpatient visits [Time frame: 1 year]
Secondary outcome measures (2)
- 1-year health-related quality of life [Time frame: 1 year]
- 1-year overall survival [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- patients ≥70 years
- diagnosed with acute cholecystitis, as per the Tokyo guidelines
Exclusion criteria
- prior episodes of cholecystitis or pancreatitis
- terminal illness
- concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL) — Alicante
Publications
- Lluis N, Perez-Brotons S, de Castro I, Martinez B, Aparicio JR, Zapater P, Lluis F, de-Madaria E. One-year outcomes by index treatment in older patients with acute cholecystitis. Protocol of the international, prospective, observational GOLDENEYE study. Cir Esp (Engl Ed). 2026 Jun;104(6):800282. doi: 10.1016/j.cireng.2025.800282. Epub 2025 Dec 23. PMID 41448354
Identifiers
NCT: NCT07006298 · Goldeneye Study