An observational study in Cirrhosis, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by NYU Langone Health · Observational
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.
3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.
This study's enrollment of 14 is below the median of 110 across 973 observational studies indexed under Fibrosis.
Browse Fibrosis studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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10 patients recruited from NYU Langone Medical Center
Exclusion Criteria:
10 Patients with body mass index (BMI) etiology of cirrhosis
Diagnostic Test: SMART Pill Pre-TIPS · 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
Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
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.
Time frame: 14 Weeks
Post TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis
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.
Time frame: 14 Weeks
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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