Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
Benign gallbladder disease, including acute cholecystitis, chronic cholecystitis, biliary dyskinesia, and biliary colic, is very common, with over 300,000 surgical cholecystectomies performed per year in the US. Unfortunately, complication rates in elderly patients or patients with many comorbidities are high. These patients are often managed with percutaneous tube drainage of the gallbladder (percutaneous cholecystostomy). The recurrence rate of calculous cholecystitis after cholecystostomy tube removal is as high as 35% at 1 year. These patients are thus faced with permanent cholecystostomy tube drainage, high-risk surgery, or cholecystostomy tube removal and risk of repeat cholecystitis. Gallbladder cryoablation is an alternative to surgical cholecystectomy which is performed percutaneously and does not require general anesthesia. Published evidence on the outcomes of gallbladder cryoablation is however limited at this point in time. The purpose of the proposed study is to follow the outcomes of high-risk patients who undergo gallbladder cryoablation.
详细描述
The purpose of the proposed research is to evaluate the outcomes of gallbladder cryoablation in high-risk surgical candidates with benign gallbladder disease (acute cholecystitis, chronic cholecystitis, biliary dyskinesia, biliary colic).
Specific Aim:
Aim 1: To evaluate the safety and efficacy of gallbladder cryoablation in high-risk surgical candidates. Patients who undergo gallbladder cryoablation will be followed long-term according to standard of care. This includes scheduled clinic follow up, laboratory analysis, and imaging as needed. We hypothesize that gallbladder cryoablation is a safe and effective treatment for high-risk surgical patients with benign gallbladder disease. Clinically, we hypothesize that patients will be free from any clinical symptoms or signs after gallbladder cryoablation and removal of a cholecystostomy tube. These include, but are not limited to right upper quadrant pain, fever, chills, and jaundice.
Aim 2: To evaluate the imaging changes seen in the gallbladder after cryoablation. Imaging is part of routine follow up after percutaneous ablation and may include CT, MRI, and nuclear medicine studies as needed. We hypothesize that after cryoablation, patients will be functionally acholecystic, which occlusion of the cystic duct and involution and fibrosis of the gallbladder demonstrated by imaging.
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
- •High-risk surgical candidates with benign gallbladder disease who are not eligible for surgical cholecystectomy and are able to consent to study inclusion.
排除标准
- •Patients with benign gallbladder disease who are eligible for surgical cholecystectomy or who are unable to provide informed consent.
研究组 & 干预措施
Gallbladder Cryoablation
High-risk patients who undergo gallbladder cryoablation
干预措施: Gallbladder Cryoablation (Device)
结局指标
主要结局
Complications
时间窗: Up to 2 years after procedure
Clavien-Dindo classification complications
Symptomatic relief
时间窗: Up to 2 years after procedure
Absence of right upper quadrant abdominal pain and nausea and absence of repeat episodes of cholecystitis, which would manifest as right upper quadrant abdominal pain associated with a fever (\>100 C) and leukocytosis.
次要结局
- Imaging(Up to 2 years after procedure)
研究者
Hugh McGregor
Associate Professor
University of Arizona