Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
研究概览
简要总结
The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative day one to check for biliary leaks.
详细描述
The purpose of this study is to evaluate how effective the Visu-Lock clip is at preventing leakage of bile (liquid made by liver and stored in gall bladder) after gallbladder surgery. It is not known if the Visu-Lock clip stops leaks better than other clips that have been used during gallbladder surgery.
Null hypothesis: There is no difference in subclinical or clinical leak rate between spring and crush clips used for cystic duct ligation.
Alternative hypothesis: Titanium spring clips decrease the rate of subclinical or clinical biliary leak from the cystic duct stump after laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Adult(18 or older)
- •Diagnosis of cholelithiasis or cholecystitis
- •Diagnosis of choledocholithiasis or biliary dyskinesia
- •scheduled fo laparoscopic cholecystectomy
- •Females: NOT pregnant
排除标准
- •Breastfeeding
- •Malignancy
- •Inflammatory bowel disease (IBD)
- •Ulcerative colitis (UC)
- •Receiving steroids
- •Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
- •History of connective tissue disorder
研究组 & 干预措施
Spring Clips
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
干预措施: 5mm spring clip (Device)
结局指标
主要结局
No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
时间窗: By post op day one HIDA scan.
次要结局
- Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.(By post op day one HIDA scan.)