EUS-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of Subjects with Complete or Partial response of treatment
研究概览
简要总结
Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant. The diagnosing specific type of cystic lesion is limited in spite of recent advances of diagnostic modalities. Surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection has significant morbidity and sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients. Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.
The purpose of this study is the double ethanol lavage is a safe and effective method for treatment in those with the indeterminate pancreas cysts.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18 and older of any gender, ethnicity and race
- •Voluntary enrollment and ability to give written informed consent
- •Capable of safely undergoing endoscopy with deep sedation or general anesthesia
- •Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)
- •Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2~4 cm in diameter
排除标准
- •Pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes)
- •Pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography
- •Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion
- •Patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL).
研究组 & 干预措施
ethanol double lavage
Endoscopic ultrasonography-guided double ethanol lavage
干预措施: Endoscopic ultrasonography-guided double ethanol lavage (Drug)
结局指标
主要结局
Rate of Subjects with Complete or Partial response of treatment
时间窗: 1 year after final treatment
Complete or partial response of treatment will be defined by the presence of a treated cystic structure, and its volume and maximum diameter in cross-sectional imaging studies (CT, MR)
次要结局
- Incidence rate of adverse events after treatment(1 year after final treatment)