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

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMART Pill Pre-TIPS

Diagnostic Test

Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies

SMART Pill Post TIPS

Diagnostic Test

Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies

Primary outcomes

Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Jul 26, 2018
Registry last updated: Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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