A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 7
- 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
研究组 & 干预措施
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
干预措施: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System (Device)
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)