8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

Portal Hypertension Clinical Trial

Official title:

Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477384
• Other study ID #: 8mm-TIPS
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2021

Study information

• Verified date: November 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Description:

For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Cirrhosis

2. Patients who had bled from esophageal varices (=5days and =28days)

3. Child-Pugh B or Child-Pugh C=13

Exclusion Criteria:

1. THE presence of gastric varices

2. Non-cirrhotic portal hypertension

3. Portal vein thrombosis

4. The history of hepatic encephalopathy

5. Total bilirubin =51.3 umol/L

6. Previous treatment of TIPS or surgery

7. Proven malignancy including hepatocellular carcinoma

8. Contraindications to TIPS?EVL or propranolol

9. End-stage renal disease under renal replacement therapy;

10. Cardiorespiratory failure

11. Pregnancy or patients not giving informed consent for endoscopic procedures

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Procedure:
• 8mm-TIPS

• Endoscopic variceal ligation

Drug:
• Propranolol

Device:
• 8mm ePTFE-covered stent

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variceal rebleeding rate	Analysis	3 years
Secondary	Hepatic encephalopathy rate	Analysis	3 years
Secondary	Number of participants with improving or worsening hepatic function	Analysis	3 years
Secondary	TIPS dysfunction rate	Analysis	3 years
Secondary	The incidence of complications	Analysis	3 years
Secondary	Number of participants with improving or worsening quality of life	Analysis	3 years
Secondary	Mortality rate	Analysis	3 years