One-year outcomes by index treatment in older patients with acute cholecystitis. Protocol of the international, prospective, observational GOLDENEYE study

IF 1.5 4区医学 Q3 SURGERY

Cirugia Espanola Pub Date : 2026-06-01 Epub Date: 2026-06-03 DOI:10.1016/j.ciresp.2025.800282

Núria Lluís , Sara Pérez-Brotons , Isabel de Castro , Belén Martínez , José R Aparicio , Pedro Zapater , Fèlix Lluís , Enrique de-Madaria

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引用次数: 0

Abstract

Background

This research project is motivated by the increasing prevalence of gallstones and biliary tract diseases in patients of advanced age, while also recognizing that the comorbidity burden of this population may necessitate a tailored treatment approach. Acute cholecystitis can rapidly progress to systemic inflammatory response syndrome, sepsis and even death. Age per se has no bearing on the severity of acute cholecystitis, but the burden of comorbidity in older patients may lead to rapid disease progression.

Methods

The GOLDENEYE study is an international, multicenter, prospective, observational research project designed to compare the outcomes of different management strategies for acute cholecystitis in seniors. The primary aims are to evaluate the efficacy of different treatments—supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage—on one-year additional treatment modalities, hospital readmissions, and outpatient care. Secondary outcomes are quality of life and survival rates. The study implements propensity score matching analysis to account for the non-randomized allocation of treatment modalities. Patients ≥ 70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, are included. 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 is performed with the REDCap platform for data entry and monitoring.

Discussion

The GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in elderly patients, ultimately improving patient outcomes and healthcare practices in this growing demographic population. ClinicalTrials.gov, NCT07006298.

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老年急性胆囊炎患者指数治疗的1年预后。国际前瞻性观察性GOLDENEYE研究方案

本研究项目的动机是由于胆结石和胆道疾病在老年患者中的患病率日益增加，同时也认识到这一人群的合并症负担可能需要量身定制的治疗方法。急性胆囊炎可迅速发展为全身炎症反应综合征、败血症甚至死亡。年龄本身与急性胆囊炎的严重程度无关，但老年患者的合并症负担可能导致疾病快速进展。方法GOLDENEYE研究是一项国际、多中心、前瞻性、观察性研究项目，旨在比较老年人急性胆囊炎不同治疗策略的结果。主要目的是评估不同治疗方法（支持治疗、经皮胆囊引流、早期或延迟胆囊切除术和eus引导下的胆囊引流）对1年额外治疗方式、再入院和门诊治疗的疗效。次要结果是生活质量和生存率。本研究采用倾向评分匹配分析来解释治疗方式的非随机分配。根据东京指南，≥70岁诊断为急性胆囊炎的患者也包括在内。排除标准包括既往胆囊炎或胰腺炎发作、绝症、急性胰腺炎、胆管炎、胆管疾病或消化道恶性肿瘤的并发诊断。数据收集是通过REDCap平台进行数据输入和监控的。GOLDENEYE研究旨在产生基于证据的见解，这将显著影响老年患者急性胆囊炎的管理，最终改善患者的治疗效果和医疗保健实践。ClinicalTrials.gov NCT07006298。

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来源期刊

Cirugia Espanola SURGERY-

CiteScore

1.20

自引率

21.10%

发文量

173

审稿时长

53 days

期刊介绍： Cirugía Española, an official body of the Asociación Española de Cirujanos (Spanish Association of Surgeons), will consider original articles, reviews, editorials, special articles, scientific letters, letters to the editor, and medical images for publication; all of these will be submitted to an anonymous external peer review process. There is also the possibility of accepting book reviews of recent publications related to General and Digestive Surgery.