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Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for High Risk Acute Variceal Bleeding in Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT01370161
Recruitment Status : Recruiting
First Posted : June 9, 2011
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):

June 7, 2011
June 9, 2011
August 1, 2017
July 2011
December 2017   (Final data collection date for primary outcome measure)
Number of survival without liver transplantation [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01370161 on ClinicalTrials.gov Archive Site
  • Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year [ Time Frame: 1 years ]
  • Number of bleeding related death [ Time Frame: 2 years ]
  • Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy) [ Time Frame: 2 years ]
Same as current
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Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for High Risk Acute Variceal Bleeding in Cirrhotic Patients
Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for High Risk Acute Variceal Bleeding in Cirrhotic Patients
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 cirrhotic patients with high risk acute variceal bleeding.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Decompensated Cirrhosis
  • Bleeding Varices
  • Procedure: Transjugular intrahepatic portosystemic shunt
    1. A 8 mm Fluency stent will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce the portal pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed.
    2. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices, in association with a PPG below 16 mmHg
    3. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted
    Other Name: Transjugular intrahepatic portosystemic shunt (TIPS)
  • Drug: Non-selective beta blocker + Endoscopic treatment

    Patients will begin treatment with non-selective beta-blockers (either propranolol or nadolol). After an initial dose of 40 mg, the dose of propranolol/nadolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm or up to the maximum tolerated dose, within the limit of 160 mg twice a day (bid) for propranolol or to a maximum of 160 mg for nadolol.

    The first elective session of endoscopic band ligation should be performed within the first 7-14 days. The following sessions will be performed at 14 + 3 days intervals until variceal eradication (defined as disappearance of the varix, impossibility of suctioning the varix, or a maximum of six continued sessions). Once eradication is achieved, a control endoscopy will be performed one month later for confirmation. The following endoscopies will be scheduled at 6 and 12 months of inclusion and yearly thereafter. If varices reappear, new band ligation will follow.

    Other Name: Non-selective beta blocker + Endoscopic variceal ligation
  • Experimental: TIPS treatment
    TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).
    Intervention: Procedure: Transjugular intrahepatic portosystemic shunt
  • Active Comparator: Medical treatment
    Patients will be treated with non-selective beta-blockers (either propranolol or nadolol). In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers but also mononitrate) and the only treatment to prevent rebleeding will be endoscopic band ligation.
    Intervention: Drug: Non-selective beta blocker + Endoscopic treatment
García-Pagán JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mössner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2018
December 2017   (Final data collection date for primary outcome measure)

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 with any of the following characteristics: one nodule of more than 5 cm; more than 3 greater than 3 cm
  • 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)
  • Portal vein thrombosis or cavernoma
  • Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
  • Spontaneous recurrent hepatic encephalopathy
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact: Zhiping Yang, MD 86-29-84771501 bayern_yang@126.com
XHDD 002
FMMU-XHDD 002 ( Registry Identifier: Fourth Military Medical University )
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Guohong Han, Fourth Military Medical University
Fourth Military Medical University
Not Provided
Principal Investigator: Guohong Han, PhD & MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Fourth Military Medical University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP