Using Covered Stent of Diameter of 7mm in TIPS

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02541825

Enrollment

216

Registered

2015-09-04

Start date

2015-08-31

Completion date

2017-12-31

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

transjugular intrahepatic portosystemic shunt

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.

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 .

Interventions

DEVICEthe stent of diameter of 7mm

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

DEVICEthe stent of diameter of 8mm

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026