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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01370161
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Bleeding Varices Procedure: TIPS treatment Drug: Medical treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Study Start Date : July 2011
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Cirrhosis

Arm Intervention/treatment
Experimental: TIPS treatment
Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.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).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days.
Procedure: TIPS treatment
  1. 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.
  2. 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.
  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)

Active Comparator: Medical treatment
Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation.
Drug: Medical treatment

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 Name: Non-selective beta blocker + Endoscopic variceal ligation




Primary Outcome Measures :
  1. Number of survival without liver transplantation [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01370161


Locations
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China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Guohong Han, PhD & MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01370161    
Other Study ID Numbers: XHDD 002
FMMU-XHDD 002 ( Registry Identifier: Fourth Military Medical University )
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Guohong Han, Fourth Military Medical University:
transjugular intrahepatic portosystemic shunt
TIPS
variceal bleeding
liver cirrhosis
hepatitis B
Additional relevant MeSH terms:
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Liver Cirrhosis
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs