Cirrhosis
Conditions
Keywords
Gut Microflora, Transjugular Intraheptic Portosystemic Shunting
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSMART Pill Pre-TIPS
Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
DIAGNOSTIC_TESTSMART Pill Post TIPS
Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis | 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. |
| Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis | 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. |
Countries
United States
Outcome results
None listed