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Status unknownNCT02485184Updated Oct 25, 2022

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

An interventional study of Transjugular intrahepatic portosystemic shunt and Non-selective beta blockers in Portal Vein Thrombosis and Liver Cirrhosis, sponsored by Air Force Military Medical University, China. Status unknown at 8 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Portal Vein Thrombosis
  • Liver Cirrhosis

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03

In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.

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Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    TIPS group

    Transjugular intrahepatic portosystemic shunt

    Procedure: Transjugular intrahepatic portosystemic shunt

  • Active comparator
    ET & drugs groups

    1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.

    Drug: Non-selective beta blockers · Procedure: Endoscopic therapy · Drug: Anticoagulation

Interventions

  • ProcedureTransjugular intrahepatic portosystemic shunt

    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.

  • DrugNon-selective beta blockers

    Non-selective beta blockers are the drugs for reducing the portal pressure.

    Also known as: propranolol

  • ProcedureEndoscopic therapy

    Endoscopic therapy includes the endoscopic variceal band ligation

  • DrugAnticoagulation

    Anticoagulation therapy includes heparin and warfarin.

    Also known as: warfarin

06

What researchers measure

Primary outcomes

  1. All-cause rebleeding or all-cause death

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

    Time frame: 3 years

Secondary outcomes

  1. Portal vein recanalization

    Incidence of portal vein recanalization

    Time frame: 3 years

  2. Other decompensations of portal hypertension

    defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome

    Time frame: 3 years

  3. adverse events of treatment

    Incidence of adverse events of treatment

    Time frame: 3 years

  4. Quality of life

    quality of life assessed by the SF-36 health survey

    Time frame: 3 years

  5. Overall survival

    Overall survival rate

    Time frame: 3 years

  6. Hepatocellular Carcinoma

    Incidence of Hepatocellular Carcinoma

    Time frame: 3 years

07

Study locations

7 of 8 sites recruiting
  • the First Affiliated Hospital, Air Force Medical University
    Xi'an, Shaanxi 710032, China
    Completed
  • Xi'an International Medical Center Hospital
    Xi'an, Shaanxi 710100, China
    • Guohong Han, MD,Ph.D · Contact · 13991969930@126.com
    • Guohong Han, MD,Ph.D · Principal investigator
    • Yong Lv, MD,Ph.D · Sub investigator
    Recruiting
  • Nanfang Hospital Affiliated to Southern Medical Univers
    Guangzhou, China
    • Jianbo Zhao, MD · Contact
    Recruiting
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, China
    • Ming-an Li, MD · Contact
    Recruiting
  • Provincial Hospital Affiliated to Shandong University
    Jinan, China
    • Chunqing Zhang, MD · Contact
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
    • Xuan Zhu, MD · Contact
    Recruiting
  • Affiliated Drum Tower Hospital of Nanjing University Medical School
    Nanjing, China
    • Yuzheng Zhuge, MD · Contact
    Recruiting
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, China
    • Weixin Ren, MD · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 20932597 ↗
  • 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. PubMed 28682164 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Dec 2024, 89 months after the start.

Of 243 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 73. This study's planned 89 months is above that.

Counting every sponsor, half of 253 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2015
First posted
Jun 30, 2015
StartActual
Jul 9, 2017
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Oct 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02485184
Lead 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
Responsible party
Guohong Han (Professor, Xi'an International Medical Center Hospital) — Principal investigator
First posted
Jun 30, 2015
Start date
Jul 9, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 25, 2022

Study contacts

Guohong Han, MD
Contact
13991969930@126.com
86-13991969930
Yong Lv, MD
Contact
lvyong126@126.com
Guohong Han, MD
principal investigator · Xi'an International Medical Center Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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