TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

Not Applicable

Recruiting

• Conditions: Portal Vein Thrombosis; Liver Cirrhosis
• Interventions: Drug: Non-selective beta blockers; Procedure: Transjugular intrahepatic portosystemic shunt; Procedure: Endoscopic therapy; Drug: Anticoagulation

• Registration Number: NCT02485184
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.

Detailed Description

Portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Study Start: 2017-07-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-22
• Last Update Posted: 2022-10-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ET & drugs groups	Non-selective beta blockers	1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.
ET & drugs groups	Endoscopic therapy	1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.
ET & drugs groups	Anticoagulation	1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.
TIPS group	Transjugular intrahepatic portosystemic shunt	Transjugular intrahepatic portosystemic shunt

Primary Outcome Measures

Name	Time	Method
All-cause rebleeding or all-cause death	3 years	Cumulative incidence of all-cause rebleeding or all-cause death

Secondary Outcome Measures

Name	Time	Method
Portal vein recanalization	3 years	Incidence of portal vein recanalization
Other decompensations of portal hypertension	3 years	defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome
adverse events of treatment	3 years	Incidence of adverse events of treatment
Quality of life	3 years	quality of life assessed by the SF-36 health survey
Overall survival	3 years	Overall survival rate
Hepatocellular Carcinoma	3 years	Incidence of Hepatocellular Carcinoma

Trial Locations

Locations (8)

the First Affiliated Hospital, Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Provincial Hospital Affiliated to Shandong University; 🇨🇳 Jinan, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, China

Xi'an International Medical Center Hospital; 🇨🇳 Xi'an, Shaanxi, China

Nanfang Hospital Affiliated to Southern Medical Univers; 🇨🇳 Guangzhou, China

Affiliated Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, China