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

NACompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Decompensated CirrhosisBleeding Varices
Interventions
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."

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."

Trial Locations (1)

710032

Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an

All Listed Sponsors
lead

Air Force Military Medical University, China

OTHER

NCT01370161 - Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis | Biotech Hunter | Biotech Hunter