Using Covered Stent of Diameter of 7mm in TIPS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

the stent of diameter of 7mm

Intervention Type DEVICE

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

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

Group Type OTHER

the stent of diameter of 8mm

Intervention Type DEVICE

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

Interventions

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the stent of diameter of 7mm

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

Intervention Type DEVICE

the stent of diameter of 8mm

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes