NCT02427906

Brief Summary

The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

April 6, 2015

Last Update Submit

October 26, 2015

Conditions

CirrhosisAcquired Portal-systemic Shunt Due to CirrhosisHepatic Encephalopathy

Keywords

cirrhosisgut microbiotatransjugular portosystemic shunthepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Changes in fecal microbiota

    baseline and 6 month

Secondary Outcomes (2)

  • Incidence of hepatic encephalopathy

    6 month

  • Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α

    baseline and 6 month

Study Arms (2)

TIPS group

patients who have transjugular intrahepatic portosystemic shunt

Non-TIPS group

patients who have endoscopic variceal ligation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital

You may qualify if:

  • Cirrhotic patients who received TIPS;
  • Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)

You may not qualify if:

  • Uncontrolled infection or sepsis;
  • Hepatobiliary or pancreatic malignancy or biliary obstruction;
  • Vital organ dysfunction;
  • Administration of antibiotics (after TIPS and 2 weeks before TIPS);
  • Cachexia;
  • Pregnant or breeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum，stool

MeSH Terms

Conditions

FibrosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Zhu Wang, PhD

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Zhu Wang, PhD

CONTACT

189817457411988wangzhu@gmail.com

Mingshan Jiang, MD

CONTACT

15680951783jmsalice333@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 28, 2015

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

CN(1)