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

NYU Langone Health

Status: Completed

Conditions: Cirrhosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT03599492

16-01360

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Cirrhosis Patients

Description:

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

Treatment:

Diagnostic Test: SMART Pill Post TIPS

Diagnostic Test: SMART Pill Pre-TIPS