One-year outcomes after different treatments for acute cholecystitis in people aged 70 and older
Official title: One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
Run by Instituto de Investigación Sanitaria y Biomédica de Alicante · NCT07006298 · Data updated 2026-11-12
This project will compare supportive care, drainage, and surgery for people 70 and older with acute cholecystitis to see which approach leads to better health and fewer repeat treatments after one year.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 376 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria y Biomédica de Alicante Research network |
| Locations | 1 site (Alicante, Alicante) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | May 15, 2027 |
| Study ends | May 15, 2027 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT07006298 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 70 or older with a new diagnosis of acute cholecystitis (Tokyo guidelines) who do not have prior cholecystitis or pancreatitis and are not terminally ill.
✕Probably not a fit
Patients younger than 70, those with prior episodes of cholecystitis or pancreatitis, terminal illness, or concurrent bile duct disease, cholangitis, or digestive malignancy are excluded and unlikely to benefit directly from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The GOLDENEYE study is a prospective, multicenter observational registry enrolling patients aged 70 and older diagnosed with acute cholecystitis according to the Tokyo guidelines. It compares initial management strategies—supportive care, percutaneous gallbladder drainage, early or delayed laparoscopic cholecystectomy, and EUS-guided gallbladder drainage—using real-world clinical practice. The protocol collects one-year outcomes including additional treatments, hospital readmissions, outpatient visits, quality of life, and survival. Propensity score matching will be applied to reduce bias from non-randomized treatment allocation and support comparative analyses.
Why it matters
Potential benefit: If successful, the results could help clinicians choose safer, more effective treatment approaches for older adults with acute cholecystitis, lowering repeat procedures, readmissions, and improving quality of life.
How similar studies have gone: Previous observational studies and some clinical trials have supported drainage or cholecystectomy in high-risk older patients, though EUS-guided gallbladder drainage remains a newer approach with limited long-term comparative data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL)
Alicante, Alicante, Spain Recruiting
Study contacts
- Study coordinator: Nuria Lluis, MD, PhD
- Email: nuria.lluis@pennmedicine.upenn.edu
- Phone: +1 (215) 662-4000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.