The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota

Conditions
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Cirrhosis

Intervention / Treatment
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* Diagnostic Test: SMART Pill Pre-TIPS
* Diagnostic Test: SMART Pill Post TIPS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhosis Patients<br>10 Patients with body mass index (BMI) etiology of cirrhosis | Diagnostic Test: SMART Pill Pre-TIPS<br>* Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies<br>Diagnostic Test: SMART Pill Post TIPS<br>* Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis | 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. | 14 Weeks | 
| Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis | 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. | 14 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microflora, Transjugular Intraheptic Portosystemic Shunting