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

NCT03599492 | Completed

• 1 other identifier: 16-01360
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

Gut Microflora; Transjugular Intraheptic Portosystemic Shunting

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Cirrhosis Patients

10 Patients with body mass index (BMI) etiology of cirrhosis

Diagnostic Test: SMART Pill Pre-TIPS; Diagnostic Test: SMART Pill Post TIPS

Interventions

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

Cirrhosis Patients

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

Cirrhosis Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 patients recruited from NYU Langone Medical Center

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bedros Taslakian, MD, EBIR

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 26, 2018
• Study Start: November 1, 2016
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)