Using Covered Stent of Diameter of 7mm in TIPS

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02541825
• Other study ID #: BeijingShijitan
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 3, 2015
• Last updated: September 3, 2015
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Beijing Shijitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Device:
• the stent of diameter of 7mm
108 patients use the stent of diameter of 7mm in TIPS
• the stent of diameter of 8mm
108 patients use the stent of diameter of 8mm in TIPS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Shijitan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hepatic encephalopathy after TIPS	The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	the incidence of shunt restenosis after TIPS	The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	the recurrence rate of gastrointestinal bleeding after TIPS	The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	Portal venous pressure before and afterTIPS	Portal venous pressure before and afterTIPS.	1 year	No
Secondary	liver function in different periods	liver function during different periods before and after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	blood ammonia in different periods	blood ammonia before and after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	jaundice index in different periods	jaundice index before and after TIPS in 7day,1,3,6,12month	1 year	No
Secondary	platelet count in different periods	platelet count before and after TIPS in 7day,1,3,6,12month	1 year	No