Clinical trial NCT06122753: Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT): A Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension
Portal Vein Thrombosis
Esophageal Varix Bleeding
Portosystemic Shunt
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Beijing YouAn Hospital
name: Beijing Friendship Hospital
name: Beijing 302 Hospital
First posted: 2023-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.

Detailed description: Portal vein thrombosis (PVT) is a common complication in patients with cirrhosis, and the cumulative incidence of PVT is 4.6%, 8.2%, and 10.7% at 1 year, 3 years, and 5 years, respectively. PVT can lead to a further increase in portal venous pressure and increase the risk of rebleeding. According to Baveno VII, PVT can be classified according to the degree of occlusion of the portal trunk as complete occlusion (no continuous luminal structure), partial occlusion (≥50% thrombus obstruction of the lumen), mild occlusion (\<50% thrombus obstruction of the lumen), or spongiotic degeneration (a large number of collateral vessels of the portal vein, with no visualization of the main portal vein). The results of a recent observational study suggested that patients with severe PVT with ≥50% thrombotic luminal obstruction had higher 6-week rebleeding rates (8.8% vs. 3.8%) and 1-year rebleeding rates (29.4% vs. 21.4%) after acute variceal bleeding. Our previous clinical study showed that patients with cirrhotic PVT treated with TIPS had lower rebleeding rates and significantly higher rates of portal vein recanalization, and it was inferred that patients with acute esophagogastric variceal bleeding with severe PVT might benefit from preemptive TIPS. Therefore, we propose to conduct a multicentre randomized controlled trial to enroll patients with acute esophagogastric variceal bleeding with occlusive PVT to compare the preemptive TIPS with the standardized therapy. The outcomes are rates of mortality, rebleeding, and complications.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
* Admission due to acute bleeding from esophagogastric varices;
* Thrombus in the main trunk of the portal vein occupying ≥50% of the lumen.

Exclusion Criteria:

* Prior treatment with TIPS or surgical shunt;
* Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
* Presence of hepatocellular carcinoma exceeding Milan criteria;
* Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;
* Presence of uncontrollable infection or sepsis;
* Presence of cardiac, pulmonary, or renal failure;
* Pregnant or lactating women;
* Refusal to sign the informed consent form.

Primary outcomes:
measure: 6-week mortality
timeFrame: 6 weeks
Secondary outcomes:
measure: 5-day treatment failure
timeFrame: 5 days
measure: 1-year mortality
timeFrame: 1 year
measure: decompensation events
timeFrame: 1 year
measure: adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xuefeng Luo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
citation: Luo X, Wang Z, Tsauo J, Zhou B, Zhang H, Li X. Advanced Cirrhosis Combined with Portal Vein Thrombosis: A Randomized Trial of TIPS versus Endoscopic Band Ligation Plus Propranolol for the Prevention of Recurrent Esophageal Variceal Bleeding. Radiology. 2015 Jul;276(1):286-93. doi: 10.1148/radiol.15141252. Epub 2015 Mar 10.