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

Primary Purpose

Portal Vein Thrombosis, Liver Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transjugular intrahepatic portosystemic shunt
Non-selective beta blockers
Endoscopic therapy
Anticoagulation
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Vein Thrombosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. liver cirrhosis (histological or clinical);
  2. Significant variceal bleeding >5 days and ≤ 42 days
  3. Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
  4. Portal vein thrombosis occlusion>=25% of the vessel lumen;
  5. Presence of ascites
  6. Child-Pugh score 8-12 at inclusion
  7. Age 18 to 70 years

Exclusion criteria

  1. Bleeding from isolated gastric or ectopic varices
  2. Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
  3. Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin>3.5 mg/dL, plasma creatinine>2.1 mg/dL, Child-Pugh score >=13points
  4. A history of significant heart failure (New York Heart Association class III and IV)
  5. Overt hepatic encephalopathy,
  6. Prehepatic portal hypertension
  7. Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
  8. Uncontrolled infection and sepsis
  9. Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
  10. Pregnancy or lactation

Sites / Locations

  • the First Affiliated Hospital, Air Force Medical University
  • Xi'an International Medical Center HospitalRecruiting
  • Nanfang Hospital Affiliated to Southern Medical UniversRecruiting
  • The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Provincial Hospital Affiliated to Shandong UniversityRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Affiliated Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TIPS group

ET & drugs groups

Arm Description

Transjugular intrahepatic portosystemic shunt

Endoscopic therapy. Non-selective beta blockers. Anticoagulation therapy.

Outcomes

Primary Outcome Measures

All-cause rebleeding or all-cause death
Cumulative incidence of all-cause rebleeding or all-cause death

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2015
Last Updated
October 22, 2022
Sponsor
Air Force Military Medical University, China
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shandong Provincial Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Southern Medical University, China, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT02485184
Brief Title
TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
Official Title
TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shandong Provincial Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Southern Medical University, China, First Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Nanchang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Thrombosis, Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS group
Arm Type
Active Comparator
Arm Description
Transjugular intrahepatic portosystemic shunt
Arm Title
ET & drugs groups
Arm Type
Active Comparator
Arm Description
Endoscopic therapy. Non-selective beta blockers. Anticoagulation therapy.
Intervention Type
Procedure
Intervention Name(s)
Transjugular intrahepatic portosystemic shunt
Intervention Description
Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.
Intervention Type
Drug
Intervention Name(s)
Non-selective beta blockers
Other Intervention Name(s)
propranolol
Intervention Description
Non-selective beta blockers are the drugs for reducing the portal pressure.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy
Intervention Description
Endoscopic therapy includes the endoscopic variceal band ligation
Intervention Type
Drug
Intervention Name(s)
Anticoagulation
Other Intervention Name(s)
warfarin
Intervention Description
Anticoagulation therapy includes heparin and warfarin.
Primary Outcome Measure Information:
Title
All-cause rebleeding or all-cause death
Description
Cumulative incidence of all-cause rebleeding or all-cause death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Portal vein recanalization
Description
Incidence of portal vein recanalization
Time Frame
3 years
Title
Other decompensations of portal hypertension
Description
defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome
Time Frame
3 years
Title
adverse events of treatment
Description
Incidence of adverse events of treatment
Time Frame
3 years
Title
Quality of life
Description
quality of life assessed by the SF-36 health survey
Time Frame
3 years
Title
Overall survival
Description
Overall survival rate
Time Frame
3 years
Title
Hepatocellular Carcinoma
Description
Incidence of Hepatocellular Carcinoma
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria liver cirrhosis (histological or clinical); Significant variceal bleeding >5 days and ≤ 42 days Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment Portal vein thrombosis occlusion>=25% of the vessel lumen; Presence of ascites Child-Pugh score 8-12 at inclusion Age 18 to 70 years Exclusion criteria Bleeding from isolated gastric or ectopic varices Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis) Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin>3.5 mg/dL, plasma creatinine>2.1 mg/dL, Child-Pugh score >=13points A history of significant heart failure (New York Heart Association class III and IV) Overt hepatic encephalopathy, Prehepatic portal hypertension Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy Uncontrolled infection and sepsis Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohong Han, MD
Phone
86-13991969930
Email
13991969930@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Lv, MD
Email
lvyong126@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han, MD
Organizational Affiliation
Xi'an International Medical Center Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital, Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Completed
Facility Name
Xi'an International Medical Center Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohong Han, MD,Ph.D
Email
13991969930@126.com
First Name & Middle Initial & Last Name & Degree
Guohong Han, MD,Ph.D
First Name & Middle Initial & Last Name & Degree
Yong Lv, MD,Ph.D
Facility Name
Nanfang Hospital Affiliated to Southern Medical Univers
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbo Zhao, MD
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-an Li, MD
Facility Name
Provincial Hospital Affiliated to Shandong University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunqing Zhang, MD
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zhu, MD
Facility Name
Affiliated Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuzheng Zhuge, MD
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weixin Ren, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20932597
Citation
Han G, Qi X, He C, Yin Z, Wang J, Xia J, Yang Z, Bai M, Meng X, Niu J, Wu K, Fan D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with symptomatic portal hypertension in liver cirrhosis. J Hepatol. 2011 Jan;54(1):78-88. doi: 10.1016/j.jhep.2010.06.029. Epub 2010 Aug 27.
Results Reference
background
PubMed Identifier
28682164
Citation
Lv Y, He C, Wang Z, Guo W, Wang J, Bai W, Zhang L, Wang Q, Liu H, Luo B, Niu J, Li K, Tie J, Yin Z, Fan D, Han G. Association of Nonmalignant Portal Vein Thrombosis and Outcomes after Transjugular Intrahepatic Portosystemic Shunt in Patients with Cirrhosis. Radiology. 2017 Dec;285(3):999-1010. doi: 10.1148/radiol.2017162266. Epub 2017 Jul 5.
Results Reference
background

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

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