Overview

This trial is active, not recruiting.

Condition liver disease
Treatments the stent of diameter of 7mm, the stent of diameter of 8mm
Phase phase 1
Sponsor Beijing Shijitan Hospital
Start date August 2015
End date December 2016
Trial size 216 participants
Trial identifier NCT02541825, BeijingShijitan

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(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
the stent of diameter of 7mm
108 patients use the stent of diameter of 7mm in TIPS
(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
the stent of diameter of 8mm
108 patients use the stent of diameter of 8mm in TIPS

Primary Outcomes

Measure
The incidence of hepatic encephalopathy after TIPS
time frame: 1 year

Secondary Outcomes

Measure
the incidence of shunt restenosis after TIPS
time frame: 1 year
the recurrence rate of gastrointestinal bleeding after TIPS
time frame: 1 year
Portal venous pressure before and afterTIPS
time frame: 1 year
liver function in different periods
time frame: 1 year
blood ammonia in different periods
time frame: 1 year
jaundice index in different periods
time frame: 1 year
platelet count in different periods
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )
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 .
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Beijing Shijitan Hospital.