The Effect of Transjugular Intraheptic Portosystemic Shun... | NCT03599492

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

NCT03599492

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Aug 9, 2022Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Cirrhosis

Interventions

SMART Pill Pre-TIPS
SMART Pill Post TIPS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Apr 12, 2022Actual

Completion Date

Apr 12, 2022Actual

First Submitted Date

Jul 12, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2022

Last Update Posted Date

Aug 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cirrhosis Patients		10 Patients with body mass index (BMI) etiology of cirrhosis	Diagnostic Test: SMART Pill Pre-TIPS Diagnostic Test: SMART Pill Post TIPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMART Pill Pre-TIPS	Diagnostic Test	Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies	Cirrhosis Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	14 Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

10 patients recruited from NYU Langone Medical Center

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bedros Taslakian, MD, EBIR	NYU Langone Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of the individual participant data collected during the trial, after deidentification.

Types

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.

URL

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms