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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Diagnostic test: SMART Pill Pre-TIPS; Diagnostic test: SMART Pill Post TIPS

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 patients recruited from NYU Langone Medical Center

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhosis Patients; 10 Patients with body mass index (BMI) etiology of cirrhosis	Diagnostic test: SMART Pill Pre-TIPS; Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies; Diagnostic test: SMART Pill Post TIPS; Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Bedros Taslakian, MD, EBIR, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): April 12, 2022
• Study Completion (ACTUAL): April 12, 2022

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Gut Microflora; Transjugular Intraheptic Portosystemic Shunting
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 16-01360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No