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

Completed

• Conditions: Cirrhosis
• Interventions: Diagnostic Test: SMART Pill Pre-TIPS; Diagnostic Test: SMART Pill Post TIPS

• Registration Number: NCT03599492
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Primary Completion: 2022-04-12
• Study Completion: 2022-04-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis Patients	SMART Pill Post TIPS	10 Patients with body mass index (BMI) etiology of cirrhosis
Cirrhosis Patients	SMART Pill Pre-TIPS	10 Patients with body mass index (BMI) etiology of cirrhosis

Primary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States