Using Covered Stent of Diameter of 7mm in TIPS

September 3, 2015 updated by: Fuquan Liu, Beijing Shijitan Hospital, Capital Medical University

Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the stent of diameter of 7mm
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
108 patients use the stent of diameter of 7mm in TIPS
Other: the stent of diameter of 8mm
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
108 patients use the stent of diameter of 8mm in TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hepatic encephalopathy after TIPS
Time Frame: 1 year
The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of shunt restenosis after TIPS
Time Frame: 1 year
The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month
1 year
the recurrence rate of gastrointestinal bleeding after TIPS
Time Frame: 1 year
The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month
1 year
Portal venous pressure before and afterTIPS
Time Frame: 1 year
Portal venous pressure before and afterTIPS.
1 year
liver function in different periods
Time Frame: 1 year
liver function during different periods before and after TIPS in 7day,1,3,6,12month
1 year
blood ammonia in different periods
Time Frame: 1 year
blood ammonia before and after TIPS in 7day,1,3,6,12month
1 year
jaundice index in different periods
Time Frame: 1 year
jaundice index before and after TIPS in 7day,1,3,6,12month
1 year
platelet count in different periods
Time Frame: 1 year
platelet count before and after TIPS in 7day,1,3,6,12month
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Shijitan Hospital, Capital Medical University

Investigators

  • Study Chair: Jianli Xu, MD PhD, Beijing Shijitan Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingShijitan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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