Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Portal HypertensionPortal Vein ThrombosisEsophageal Varix BleedingPortosystemic Shunt
Interventions
PROCEDURE

preemptive TIPS

The TIPS procedure should be performed within 72 hours after the initial endoscopic examination or treatment. An 8 mm Viatorr stent will be used for TIPS establishment. The aim will be to reduce the portal pressure gradient below 12 mm Hg. Embolization, either with coils or glue, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule but is allowed if the attending physician thinks that it is warranted.

PROCEDURE

standard second prophylaxis

"Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (carvedilol) will be started with an initial dose of 6.25 mg, the dose of propranolol will be increased to 12.5 mg.~The second elective session of endoscopic band ligation will be performed within the first 28 days after the initial endoscopic treatment. The following sessions will be performed at 28 +/- 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)

610000

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

collaborator

Beijing YouAn Hospital

OTHER

collaborator

Beijing Friendship Hospital

OTHER

collaborator

Beijing 302 Hospital

OTHER

lead

West China Hospital

OTHER

NCT06122753 - Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis | Biotech Hunter | Biotech Hunter