Clinical trial NCT07006298: One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis
Official title: One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Cholecystitis
Keywords: laparoscopic cholecystectomy
Conservative Treatment
drainage
Endosonography
Propensity Score
Retrospective Studies
Lead sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante
Sponsor class: NETWORK
First posted: 2025-06-05
Enrollment: 376
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines

Brief 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 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

Primary outcomes:
measure: 1 year additional procedures, hospital readmissions or outpatient visits
timeFrame: 1 year
Secondary outcomes:
measure: 1-year health-related quality of life
timeFrame: 1 year
measure: 1-year overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
Study officials:
References: