NCT02541825

Brief Summary

This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2015

Typical duration for phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

September 3, 2015

Last Update Submit

September 3, 2015

Conditions

Liver Disease

Keywords

transjugular intrahepatic portosystemic shunt

Outcome Measures

Primary Outcomes (1)

  • The incidence of hepatic encephalopathy after TIPS

    The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month

    1 year

Secondary Outcomes (7)

  • the incidence of shunt restenosis after TIPS

    1 year

  • the recurrence rate of gastrointestinal bleeding after TIPS

    1 year

  • Portal venous pressure before and afterTIPS

    1 year

  • liver function in different periods

    1 year

  • blood ammonia in different periods

    1 year

  • +2 more secondary outcomes

Study Arms (2)

the stent of diameter of 7mm

EXPERIMENTAL

Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No

Device: the stent of diameter of 7mm

the stent of diameter of 8mm

OTHER

Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No

Device: the stent of diameter of 8mm

Interventions

the stent of diameter of 7mmDEVICE

108 patients use the stent of diameter of 7mm in TIPS

the stent of diameter of 7mm
the stent of diameter of 8mmDEVICE

108 patients use the stent of diameter of 8mm in TIPS

the stent of diameter of 8mm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
  • undergoing elective TIPS to treat patients.
  • aged 18-70 years old

You may not qualify if:

  • preoperative patients with hepatic encephalopathy.
  • with portal vein thrombosis patients.
  • combined liver malignant tumor or other parts of the patients with malignant tumor.
  • In combination of peptic ulcer bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Jianli Xu, MD PhD

    Beijing Shijitan Hospital, Capital Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Clinical Research

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 4, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

September 4, 2015

Record last verified: 2015-09