Using Covered Stent of Diameter of 7mm in TIPS

Beijing Shijitan Hospital, Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Liver Disease

Treatments: Device: the stent of diameter of 8mm; Device: the stent of diameter of 7mm

Study type: Interventional

Funder types: Other

Identifiers

NCT02541825

BeijingShijitan

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

the stent of diameter of 7mm

Experimental group

Description:

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

Treatment:

Device: the stent of diameter of 7mm

the stent of diameter of 8mm

Other group

Description:

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

Treatment:

Device: the stent of diameter of 8mm