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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2022-04-12

Brief Summary

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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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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis Patients

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

SMART Pill Pre-TIPS

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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SMART Pill Pre-TIPS

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No