The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
研究概览
简要总结
The effect of portal hypertension on gastrointestinal motility, and how reversal or improvement in portal hypertension may alter gastrointestinal motility, remains unclear and further research is needed. Additionally, patients with cirrhosis have altered gut microflora, particularly rich in lactobacilli, including enterococci and bifidobacteria. Transjugular Intraheptic Portosystemic Shunting (TIPS) is a procedure performed by interventional radiologists, in which a connection is made between the portal and venous circulations, allowing high pressure portal blood to more easily enter the systemic circulation and bypass the liver; thus effectively decreased portal pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with either radiographic or biopsy proven decompensated cirrhosis (as determined by ascites, variceal hemorrhage, encephalopathy or jaundice).
- •Patients undergoing an elective TIPS for any standard of care established indication (examples: worsening ascites, recurrent variceal bleeding).
排除标准
- •Pregnant women.
- •Patients unwilling or unable to provide informed consent.
- •Patients undergoing an emergent TIPS for acute or subacute variceal hemorrhage.
- •Patients with diabetes, significant cardiovascular, renal or other chronic disease which has been known to affect intestinal motility.
- •Previously diagnosed gastroparesis or other GI dysmotility disorder.
- •Patients currently taking narcotics, antibiotics excluding rifaximin, prokinetic medications or lactulose.
- •Patients with a history of gastric bezoar.
- •Patients with a history of multiple intestinal surgeries or GI surgery within the past 3 months.
- •Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
- •Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
- •Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
- •Patients with a history of diverticulitis.
- •Patients with swallowing disorders and increased risk of aspiration (such as prior history of aspiration).
- •Patient with Celiac disease.
- •Patients with implanted or portable electro-mechanical medical devices.
结局指标
主要结局
Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
时间窗: 14 Weeks
Due to small sample size, Wilcoxon rank-sum test will be used to compare the continuous variable of gut transit times. A p-value of \<0.05 will be considered statistically significant.
Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
时间窗: 14 Weeks
Due to small sample size, Wilcoxon rank-sum test will be used to compare the continuous variable of gut transit times. A p-value of \<0.05 will be considered statistically significant.
次要结局
未报告次要终点