Recurrence of Acute Cholecystitis After EUS-Guided Gallbladder Drainage Versus Cholecystectomy in Elderly Patients: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Recurrence rate of cholecystitis within 24 months
研究概览
简要总结
Acute cholecystitis is common in elderly patients and becomes more frequent with increasing age. Standard treatment is laparoscopic cholecystectomy (LCC), but operative treatment may be associated with increased risk in older patients with substantial comorbidity or reduced tolerance of general anesthesia.
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is a minimally invasive internal drainage procedure performed through the stomach or duodenum using endoscopic ultrasound guidance and a lumen-apposing metal stent. This approach may provide an alternative to operative treatment in selected elderly patients.
The CHOICE study (CHolecystitis Outcomes in the Investigation of Cholecystectomy versus EUS-GBD) is a multicenter randomized controlled trial comparing EUS-GBD with LCC in patients aged 75 years or older with acute cholecystitis. Participants are randomly assigned to undergo either laparoscopic removal of the gallbladder or endoscopic ultrasound-guided internal gallbladder drainage.
The objective of the study is to determine whether EUS-GBD provides clinically acceptable outcomes compared with standard operative treatment in this patient population. Participants are followed using medical record review and scheduled follow-up contacts.
详细描述
The CHOICE trial is an investigator-initiated, multicenter, randomized controlled trial conducted in Finnish hospitals. The trial compares endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with laparoscopic cholecystectomy (LCC) in elderly patients with acute cholecystitis.
LCC is the standard operative treatment for acute cholecystitis. In elderly patients, clinical decision-making may be affected by comorbidity, frailty, reduced physiological reserve, and limited tolerance of general anesthesia. EUS-GBD is an internal drainage procedure performed under endoscopic ultrasound guidance using a lumen-apposing metal stent. The procedure is intended to achieve gallbladder drainage without surgical removal of the gallbladder.
After enrolment, participants are randomized in a 1:1 ratio to either LCC or EUS-GBD using centralized computer-generated allocation through REDCap. Both treatment groups receive standard antimicrobial treatment according to local clinical practice.
LCC is performed according to the standard operative practice of each participating hospital using a laparoscopic approach. EUS-GBD is performed under propofol sedation with endoscopic ultrasound guidance. The preferred access route is transduodenal, with transgastric access used when required by anatomical or technical factors. A lumen-apposing metal stent is placed to create internal drainage between the gallbladder and the gastrointestinal tract.
In the EUS-GBD group, stent management is planned according to the study protocol and clinical circumstances. In general, the lumen-apposing metal stent may be replaced with a plastic pigtail stent after maturation of the fistulous tract. In patients with limited life expectancy or other clinical considerations, the lumen-apposing metal stent may be left in place at the discretion of the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 75 years or older.
- •Radiologically confirmed acute cholecystitis.
- •Elevated inflammatory parameters.
- •Able to provide written informed consent.
- •Able to complete follow-up questionnaires.
排除标准
- •Age under 75 years.
- •Considered unfit for surgery.
- •ASA physical status classification below III.
- •Unwillingness to participate in follow-up assessments.
- •Lack of written informed consent.
- •Clinical Frailty Scale score of 8 or higher.
研究组 & 干预措施
LCC
Laparoscopic cholecystectomy
干预措施: LCC (Procedure)
EUS-GBD
Endoscopic ultrasonography-guided gallbladder drainage
干预措施: EUS-GBD (Procedure)
结局指标
主要结局
Recurrence rate of cholecystitis within 24 months
时间窗: From the index intervention to 24 months after the index intervention
Proportion of participants with recurrent acute cholecystitis within 24 months after the index intervention. Recurrent cholecystitis is defined as a new episode of clinically suspected acute cholecystitis supported by radiological findings and elevated inflammatory parameters.
Length of index hospital stay
时间窗: From hospital admission for acute cholecystitis to discharge from the index hospitalization, assessed up to 90 days
Duration of the index hospital stay, measured in days from hospital admission for acute cholecystitis to discharge from the index hospitalization.
次要结局
- Duration of antibiotic treatment(From hospital admission for acute cholecystitis to completion of antibiotic treatment for the index episode, assessed up to 90 days)
- Length of intensive care unit stay(From the index intervention to hospital discharge from the index hospitalization, assessed up to 90 days)
- Post-interventional complications according to the Clavien-Dindo classification(From the index intervention to 90 days after the index intervention)
- Organ-specific postoperative complications(From the index intervention to 90 days after the index intervention)
- Procedure-specific complications(From the index intervention to 90 days after the index intervention)
- Ninety-day mortality(From the index intervention to 90 days after the index intervention)
- Long-term mortality(From the index intervention to 10 years after the index intervention)
- Long-term recurrence of cholecystitis after 24 months(From 24 months after the index intervention to 10 years after the index intervention)
- Direct hospital costs(From hospital admission for acute cholecystitis to 24 months after the index intervention)
研究者
Heikki Huhta
PI
Oulu University Hospital