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 )

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: Liver Disease
• Intervention / Treatment: Device: the stent of diameter of 7mm; Device: the 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 .

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 1

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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: transjugular intrahepatic portosystemic shunt
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: BeijingShijitan