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

Instituto de Investigación Sanitaria y Biomédica de Alicante

Status: Enrolling

Conditions: Acute Cholecystitis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07006298

Goldeneye Study

Details and patient eligibility

About

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.

Enrollment: 376 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

376 participants in 4 patient groups

Supportive care

Description:

Patients that received antibiotics only

Cholecystectomy

Description:

Patients that undergo early or delayed cholecystectomy

percutaneous gallbladder drainage

Description:

Patients that undergo percutaneous gallbladder drainage

EUS-guided gallbladder drainage

Description:

Patients that undergo EUS-guided gallbladder drainage