Acute CholecystitisGOLDENEYENCT07006298
One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis
An observational study of Acute Cholecystitis, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 376 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines
Who may be able to join
- patients ≥70 years
- diagnosed with acute cholecystitis, as per the Tokyo guidelines
Who cannot join
- prior episodes of cholecystitis or pancreatitis
- terminal illness
- concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
Alicante, Alicante, 03010
Felix Lluis, MD, PhD, +34 601-023-068, goldeneye@isabial.es
Felix Lluis, MD, PhD
About this study
Official title: One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
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
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
1-year health-related quality of life
The EQ-5D-5L questionnaire is used to assess quality of life in elderly individuals. It encompasses five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated across five severity levels. Level 1 indicates that the patient has no problems. Level 5 indicates the worst condition. Additionally, the questionnaire has a scale. This scale is numbered from 0 to 100. A score of 100 indicates the best health possible. Zero means the worst health possible. Measurements will be obtained during the initial admission and at one, three, and twelve months.
Measured: 1 year
1-year overall survival
Survival will be defined as the time elapsed between the date of index admission and the date of death or last follow-up. Survival curves will be constructed by the Kaplan-Meier method and compared using the log-rank test. A multivariable Cox proportional hazards regression model will be used to identify prognostic factors associated with survival. All variables that are significant at 0.10 in the univariable analysis will be entered into a multivariable model. P-values less than 0.05 will be considered statistically significant. All analyses will be performed with RStudio, version 1.2.5001 (Integrated Development for R. RStudio, Inc., Boston, MA, USA).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 May 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de Alicante
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nuria Lluis Viñas, Instituto de Investigación Sanitaria y Biomédica de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006298
- Sponsor's protocol ID
- Goldeneye Study
- Acronym
- GOLDENEYE
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Steering Committee and statistical advisors will have access to the final dataset. Members of the GOLDENEYE study that recruited patients may claim access to the final dataset to perform ancillary studies; the Steering Committee will study these proposals. Any data required to support the protocol can be supplied on request.
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.
PubMed 41448354
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
- ClinicalTrials.gov ID
- NCT07006298
- Acronym / sponsor ID
- GOLDENEYE / Goldeneye Study
- Conditions
- Acute Cholecystitis
- Keywords
- laparoscopic cholecystectomy, Conservative Treatment, drainage, Endosonography, Propensity Score, Retrospective Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de AlicanteResearch network
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines
Key inclusion criteria (2 listed)
- patients ≥70 years
- diagnosed with acute cholecystitis, as per the Tokyo guidelines
Key exclusion criteria (3 listed)
- prior episodes of cholecystitis or pancreatitis
- terminal illness
- concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1 year additional procedures, hospital readmissions or outpatient visits
Time frame: 1 year
Percentage of patients requiring any additional procedure, hospital readmission or outpatient visit during the first year.
2 secondary outcomes
1-year health-related quality of life
Time frame: 1 year
1-year overall survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 41448354Lluis 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The Steering Committee and statistical advisors will have access to the final dataset. Members of the GOLDENEYE study that recruited patients may claim access to the final dataset to perform ancillary studies; the Steering Committee will study these proposals. Any data required to support the protocol can be supplied on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuria Lluis, MD, PhD (+1 (215) 662-4000, nuria.lluis@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year additional procedures, hospital readmissions or outpatient visits (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.