NCT03767881已完成不适用
A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 14
- 主要终点
- Number of Days to Resolution of Acute Cholecystitis
研究概览
简要总结
To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.
详细描述
This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring intervention for the management of symptoms associated with acute cholecystitis
- •Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health
- •Eligible for endoscopic intervention
- •Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:
- •AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met.
- •AC Grade II (moderate) defined by any one of the following characteristics
- •Leukocytosis (>18,000 cells per mm3)
- •Palpable, tender mass in right upper quadrant
- •Symptom duration >72 hours
- •Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis)
- •Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion
- •18 years of age or older
- •Willing and able to comply with the study procedures and patient or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
排除标准
- •AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems:
- •Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine
- •Neurologic - decreased level of consciousness
- •Respiratory - PaO2/FiO2 <300
- •Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter)
- •Hepatic - International normalized ratio >1.5
- •Hematologic - Platelet count <100,000/mm3
- •Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder
- •Hepatic abscess
- •Patients with abnormal coagulation or who require ongoing complete anticoagulation
- •Bleeding diathesis
- •History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)
- •Patients with a current percutaneous drainage
- •Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal
- •Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage
- •Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location
- •Patients that have allergies or are sensitive to any of the device materials
- •Patients with contraindications to use of electrical devices
- •Prisoners and other vulnerable populations
结局指标
主要结局
Number of Days to Resolution of Acute Cholecystitis
时间窗: Up to 15 weeks
Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
次要结局
- Rate of Re-interventions(Through study completion, Up to 15 weeks)
研究者
研究点 (14)
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