One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• patients ≥70 years

• diagnosed with acute cholecystitis, as per the Tokyo guidelines

Locations
Other Locations
Spain
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
RECRUITING
Alicante
Contact Information
Primary
Nuria Lluis, MD, PhD
nuria.lluis@pennmedicine.upenn.edu
+1 (215) 662-4000
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 376
Treatments
Supportive care
Patients that received antibiotics only
Cholecystectomy
Patients that undergo early or delayed cholecystectomy
percutaneous gallbladder drainage
Patients that undergo percutaneous gallbladder drainage
EUS-guided gallbladder drainage
Patients that undergo EUS-guided gallbladder drainage
Sponsors
Leads: Instituto de Investigación Sanitaria y Biomédica de Alicante

This content was sourced from clinicaltrials.gov