Clinical trial NCT03599492: The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
Official title: The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Keywords: Gut Microflora
Transjugular Intraheptic Portosystemic Shunting
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients recruited from NYU Langone Medical Center

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
timeFrame: 14 Weeks
measure: Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
timeFrame: 14 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bedros Taslakian, MD, EBIR
role: PRINCIPAL_INVESTIGATOR
References: