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

NCT06122753 | Not Yet Recruiting

• 1 other identifier: pTIPS-PVT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Portal Vein Thrombosis; Esophageal Varix Bleeding; Portosystemic Shunt

Outcome Measures

Primary Outcomes (1)

• 6-week mortality

  The rate of mortality during the first 6 weeks after inclusion in the study.

  6 weeks

Secondary Outcomes (4)

• 5-day treatment failure

  5 days

• 1-year mortality

  1 year

• decompensation events

  1 year

• adverse events

  1 year

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Standard combined endoscopic and pharmacological therapy as secondary prophylaxis (carvedilol + repeated endoscopic variceal ligation until the eradication of the esophageal varices).

Procedure: standard second prophylaxis

Preemptive TIPS

EXPERIMENTAL

Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Performance of TIPS in the first 72 hours following initial endoscopic hemostasis.

Procedure: preemptive TIPS

Interventions

preemptive TIPS PROCEDURE

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.

Also known as: early TIPS

Preemptive TIPS

standard second prophylaxis PROCEDURE

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.

Also known as: endoscopy plus drug treatment

Standard Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Beijing YouAn Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Beijing 302 Hospital: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Related Publications (2)

• 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.

  PMID: 37606572 BACKGROUND

• 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.

  PMID: 25759969 RESULT

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Xuefeng Luo, Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiazoe Wang, M.D.

CONTACT

+8615208207573; wang_xiaoze@wchscu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

CN (1)