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Completed

NCT Number: NCT01370161

Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.

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Key information

Conditions

Decompensated Cirrhosis Bleeding Varices Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of cirrhosis (clinical or by liver biopsy)
  • Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
  • Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
  • Signed written informed consent

Exclusion criteria

  • Patients not fulfilling inclusion criteria
  • Pregnancy or breast-feeding
  • Confirmed hepatocellular carcinoma
  • Creatinine greater than 3 mg/dl
  • Terminal hepatic failure (Child-Pugh score greater than 13)
  • Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
  • Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
  • Complete portal vein thrombosis or portal cavernoma
  • Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
  • Spontaneous recurrent hepatic encephalopathy

Treatment and study plan

TIPS treatment

Procedure
  • A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
  • Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.
  • After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.

Other names: Transjugular intrahepatic portosystemic shunt (TIPS)

medical treatment

Drug

Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.

The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.

Other names: Non-selective beta blocker + Endoscopic variceal ligation

Primary outcomes

  1. Number of survival without liver transplantation

    Time frame: 2 years

Secondary outcomes

  1. Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year

    Time frame: 1 years

  2. Number of bleeding related death

    Time frame: 2 years

  3. Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2011
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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