Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Complication rate.
研究概览
简要总结
This study intends to evaluate the security and success rate of large bore percutaneous radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.
详细描述
Percutaneous gastrostomy is a procedure that intends to provide prolonged alimentary access to patients with normal gastrointestinal tract, which are unable to eat or are facing troubles with deglutition.
Nowadays it is considered as the first line procedure to prolonged enteral access on this patients.
The indications to perform a percutaneous gastrostomy in a cancer center are usually related to head and neck, central nervous system and esophagus tumors. In our institution around 80% of the percutaneous gastrostomy are performed in patients with head an neck tumors.
Although percutaneous gastrostomy is considered a safe procedure, there are some complications related, specially in oncologic patients. Those complications are reported in about 40% of the cases.
Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to hospitalization costs. However, some studies have shown that is safe and viable to perform percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in patients with head a neck tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Surgical risk ASA I-III, Karnofsky Performance Status >70, acceptance and comprehension of the orientations and after-care, adequate social a familiar support, easy access to the hospital.
排除标准
- •patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol.
结局指标
主要结局
Complication rate.
时间窗: Up to 24 weeks.
Rate of other complications like bleeding, infection, cutaneous fistulae.
次要结局
- Pain intensity.(Immediately after the procedure and during the total follow-up period - Up to 24 weeks.)
- Duration of gastrostomy.(Up to 24 weeks.)
- Technical success rate.(Immediately.)
- Additional procedures.(Up to 24 weeks.)
- Procedure duration time.(Immediately after the procedure.)