TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV

Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)

To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Portal Vein Thrombosis; Bleeding Esophageal Varices; Portal Vein, Cavernous Transformation of
• Intervention / Treatment: Procedure: TIPS; Drug: Warfarin; Drug: Propranolol; Procedure: Endoscopic therapy

Detailed Description

The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tao Pan; Phone Number: 8602085252066; Email: pant5@mail2.sysu.edu.cn
• Study Contact Backup: Name: Zaibo Jiang; Phone Number: 8602085253416; Email: jiangzaibo@aliyun.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Department of Radiology
      • Contact: Zaibo Jiang, MD.; Phone Number: +86 020 85253416; Email: jiangzaibo@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
• History of variceal bleeding.
• Liver cirrhosis.
• Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
• Albumin ≥2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit.
• PT(Prothrombin time)-INR(international normalized ratio) < 1.7.

Exclusion Criteria:

• Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
• Company with malignant tumors in liver or other organs.
• Patients with known severe dysfunction of heart, lung, brain or kidney.
• Active bleeding.
• Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
• Uncontrolled infection.
• Pregnancy and breastfeeding.
• HIV infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS arm; Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.	Procedure: TIPS; Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.; Other Names: Transjugular intrahepatic portosystemic shunt; Drug: Warfarin; Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.
Active Comparator: conservative treatment arm; Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).	Drug: Warfarin; Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.; Drug: Propranolol; Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.; Procedure: Endoscopic therapy; Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variceal rebleeding	Variceal rebleeding rate in 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival time		3 years
Variceal rebleeding-related death rate		3 years
Treatment-related complications	Incidence of treatment-related complications	3 years
Transjugular intrahepatic portosystemic shunt success rate	Technical success rate of transjugular intrahepatic portosystemic shunt	3 years

Collaborators and Investigators

• Sponsor: Zaibo Jiang
• Investigators: Principal Investigator: Zaibo Jiang, Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 24, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Embolism and Thrombosis; Fibrosis; Esophageal Diseases; Hypertension, Portal; Liver Cirrhosis; Esophageal and Gastric Varices; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Anticoagulants; Propranolol; Warfarin
• Other Study ID Numbers: TIPSVRDORNO3HSYSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided