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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599492
• Other study ID #: 16-01360
• Status: Completed
• Start date: November 2016
• Est. completion date: April 12, 2022

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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