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NCT03599492 · ClinicalTrials.gov registry record
The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 14
- Enrollment target
NCT03599492: Completed study, sponsored by NYU Langone Health.
NCT03599492 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03599492 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST SMART Pill Pre-TIPS
- DIAGNOSTIC_TEST SMART Pill Post TIPS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-11 |
| Est. Completion | 2022-04-12 |
What the finished NCT03599492 record still lists
NCT03599492 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which SMART Pill Pre-TIPS is the first listed.
NCT03599492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03599492 about?
NCT03599492 is a clinical study titled "The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota". 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 lactobac...
What is the current status of trial NCT03599492?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2016-11. Estimated completion is 2022-04-12.
What interventions are being tested in trial NCT03599492?
The interventions under investigation include: SMART Pill Pre-TIPS (DIAGNOSTIC_TEST), SMART Pill Post TIPS (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03599492?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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