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 : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Bleeding Varices||Procedure: Transjugular intrahepatic portosystemic shunt Drug: Non-selective beta blocker + Endoscopic treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 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 High Risk Acute Variceal Bleeding in Cirrhotic Patients|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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).
Procedure: Transjugular intrahepatic portosystemic shunt
Other Name: Transjugular intrahepatic portosystemic shunt (TIPS)
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.
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
- 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
|Contact: Zhiping Yang, MDemail@example.com|
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Zhiping Yang, MD 86-29-84771501 firstname.lastname@example.org|
|Contact: Xingshun Qi, MD 86-29-84771528 email@example.com|
|Principal Investigator: Guohong Han, PhD & MD|
|Principal Investigator:||Guohong Han, PhD & MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|