One-year outcomes after different treatments for acute cholecystitis in people aged 70 and older
One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study
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 |
|---|---|
| Enrollment | 376 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria y Biomédica de Alicante Research network |
| Locations | 1 site (Alicante, Alicante) |
| Trial ID | NCT07006298 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alicante, Alicante
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.