Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01370161|
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Bleeding Varices||Procedure: TIPS treatment Drug: Medical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- Number of survival without liver transplantation [ Time Frame: 2 years ]
- 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 ]
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
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han, PhD & MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|