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

NCT02853526 | Unknown Phase 3

• 1 other identifier: TIPSVRDORNO3HSYSU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Portal Vein, Cavernous Transformation of; Portal Vein Thrombosis; Liver Cirrhosis; Bleeding Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• Variceal rebleeding

  Variceal rebleeding rate in 3 years

  3 years

Secondary Outcomes (4)

• Overall survival time

  3 years

• Variceal rebleeding-related death rate

  3 years

• Treatment-related complications

  3 years

• Transjugular intrahepatic portosystemic shunt success rate

  3 years

Study Arms (2)

TIPS arm

EXPERIMENTAL

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; Drug: Warfarin

conservative treatment arm

ACTIVE COMPARATOR

Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).

Drug: Propranolol; Procedure: Endoscopic therapy; Drug: Warfarin

Interventions

TIPS PROCEDURE

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.

Also known as: Transjugular intrahepatic portosystemic shunt

TIPS arm

Propranolol DRUG

Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.

conservative treatment arm

Endoscopic therapy PROCEDURE

Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

conservative treatment arm

Warfarin DRUG

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.

TIPS arm; conservative treatment arm

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zaibo Jiang: lead

Study Sites (1)

Department of Radiology

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Portal Vein, Cavernous Transformation Of; Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic; Propranolol; Warfarin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zaibo Jiang

  Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Pan

CONTACT

8602085252066; pant5@mail2.sysu.edu.cn

Zaibo Jiang

CONTACT

8602085253416; jiangzaibo@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the intervention and vascular surgery department, the Third Affiliated Hospital, Sun Yat-sen University

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: August 3, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 3, 2016

Record last verified: 2016-07

Locations

CN (1)