CirrhosisNCT03599492
The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
An observational study of Cirrhosis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- SMART Pill Pre-TIPS and SMART Pill Post TIPS
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 12 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients recruited from NYU Langone Medical Center
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cirrhosis
- Being tested
- SMART Pill Pre-TIPS, SMART Pill Post TIPS
- Keywords
- Gut Microflora, Transjugular Intraheptic Portosystemic Shunting
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Pill Pre-TIPSDiagnostic test
Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
SMART Pill Post TIPSDiagnostic test
Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis Patients | 10 Patients with body mass index (BMI) etiology of cirrhosis Receives: Diagnostic Test: SMART Pill Pre-TIPS; Diagnostic Test: SMART Pill Post TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startNov 2016
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bedros Taslakian, MD, EBIR, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599492
- Sponsor's protocol ID
- 16-01360
- Status last verified
- Aug 2022
- First submitted
- 12 Jul 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transjugular Intraheptic Portosystemic Shunt (TIPS) on Gastrointestinal Motility and the Gut Microbiota
- ClinicalTrials.gov ID
- NCT03599492
- Acronym / sponsor ID
- 16-01360
- Conditions
- Cirrhosis
- Keywords
- Gut Microflora, Transjugular Intraheptic Portosystemic Shunting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis Patients | – | Diagnostic Test: SMART Pill Pre-TIPS, Diagnostic Test: SMART Pill Post TIPS10 Patients with body mass index (BMI) etiology of cirrhosis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients recruited from NYU Langone Medical Center
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART Pill Pre-TIPSAssessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies | Diagnostic test | Cirrhosis Patients |
| SMART Pill Post TIPSAssessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies | Diagnostic test | Cirrhosis Patients |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bedros Taslakian, MD, EBIR principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-TIPS intestinal transit time (measured in hours and minutes), via smart pill in patients with cirrhosis (time frame: 14 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.