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

NCT07006298 | Recruiting DMC

• 1 other identifier: Goldeneye Study
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

laparoscopic cholecystectomy; Conservative Treatment; drainage; Endosonography; Propensity Score; Retrospective Studies

Outcome Measures

Primary Outcomes (1)

• 1 year additional procedures, hospital readmissions or outpatient visits

  Percentage of patients requiring any additional procedure, hospital readmission or outpatient visit during the first year.

  1 year

Secondary Outcomes (2)

• 1-year health-related quality of life

  1 year

• 1-year overall survival

  1 year

Study Arms (4)

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines

You may qualify if:

• patients ≥70 years
• diagnosed with acute cholecystitis, as per the Tokyo guidelines

You may not qualify if:

• prior episodes of cholecystitis or pancreatitis
• terminal illness
• concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy

Sponsors & Collaborators

• Instituto de Investigación Sanitaria y Biomédica de Alicante: lead

Study Sites (1)

Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)

Alicante, Alicante, 03010, Spain

RECRUITING

Related Publications (1)

• 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). 2025 Dec 23:800282. doi: 10.1016/j.cireng.2025.800282. Online ahead of print.

  PMID: 41448354 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Nuria Lluis, MD, PhD

CONTACT

+1 (215) 662-4000; nuria.lluis@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)