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

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ClinicalTrials.gov Identifier: NCT03599492
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cirrhosis Diagnostic Test: SMART Pill Pre-TIPS Diagnostic Test: SMART Pill Post TIPS

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
Actual Study Start Date : November 2016
Estimated Primary Completion Date : February 25, 2022
Estimated Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
Cirrhosis Patients
10 Patients with body mass index (BMI) etiology of cirrhosis
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

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




Primary Outcome Measures :
  1. Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis [ Time Frame: 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.

  2. Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
10 patients recruited from NYU Langone Medical Center
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599492


Contacts
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Contact: Simone Rainey 212 263 2710 Simone.Rainey@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Simone Rainey    212-263-2710    Simone.Rainey@nyumc.org   
Principal Investigator: Akhilesh Sista, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Akhilesh Sista NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03599492    
Other Study ID Numbers: 16-01360
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Gut Microflora
Transjugular Intraheptic Portosystemic Shunting
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes