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

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ClinicalTrials.gov Identifier: NCT02853526
Recruitment Status : Unknown
Verified July 2016 by Zaibo Jiang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Zaibo Jiang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Portal Vein, Cavernous Transformation of Portal Vein Thrombosis Liver Cirrhosis Bleeding Esophageal Varices Procedure: TIPS Drug: Propranolol Procedure: Endoscopic therapy Drug: Warfarin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018


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 Name: 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: 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.

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.




Primary Outcome Measures :
  1. Variceal rebleeding [ Time Frame: 3 years ]
    Variceal rebleeding rate in 3 years


Secondary Outcome Measures :
  1. Overall survival time [ Time Frame: 3 years ]
  2. Variceal rebleeding-related death rate [ Time Frame: 3 years ]
  3. Treatment-related complications [ Time Frame: 3 years ]
    Incidence of treatment-related complications

  4. Transjugular intrahepatic portosystemic shunt success rate [ Time Frame: 3 years ]
    Technical success rate of transjugular intrahepatic portosystemic shunt



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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853526


Contacts
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Contact: Tao Pan 8602085252066 pant5@mail2.sysu.edu.cn
Contact: Zaibo Jiang 8602085253416 jiangzaibo@aliyun.com

Locations
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China, Guangdong
Department of Radiology Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Zaibo Jiang, MD.    +86 020 85253416    jiangzaibo@aliyun.com   
Sponsors and Collaborators
Zaibo Jiang
Investigators
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Principal Investigator: Zaibo Jiang Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Zaibo Jiang, Head of the intervention and vascular surgery department, the Third Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02853526     History of Changes
Other Study ID Numbers: TIPSVRDORNO3HSYSU
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Liver Cirrhosis
Esophageal and Gastric Varices
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Propranolol
Warfarin
Anticoagulants
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents