What side effects are associated with this type of intervention?

Common treatments for liver disease, particularly those involving portal vein access such as TIPS (Transjugular Intrahepatic Portosystemic Shunt), can have several side effects. These include nausea, abdominal pain, fatigue, and transient hyperbilirubinemia. More serious complications can include portal vein thrombosis, hepatic encephalopathy, and infection. Additionally, procedures like radioembolization and proton beam irradiation may cause gastrointestinal toxicities and hepatobiliary disorders such as ascites and gallbladder obstruction.

What prior FDA approvals exist?

The FDA has approved several treatments for liver disease, particularly for conditions that may require interventions similar to the creation of a parenchymal tract between the portal vein and hepatic vein. One notable procedure is the Transjugular Intrahepatic Portosystemic Shunt (TIPS), which is used to treat complications of portal hypertension, such as variceal bleeding and refractory ascites. Additionally, drugs like sorafenib and lenvatinib have been approved for advanced hepatocellular carcinoma, a common liver cancer. These treatments aim to manage symptoms and improve survival in patients with severe liver conditions.

What other types of research exist?

Promising novel alternatives to Portal Vein Access Sets for liver disease patients include: 1) Accessory hepatic vein recanalization, which has shown 100% technical success in treating hepatic vein-type Budd-Chiari syndrome. 2) Percutaneous extrahepatic portosystemic shunt (PEPS) creation, which has been assessed for anatomic feasibility and could offer a less invasive option. 3) Advanced imaging techniques such as three-dimensional roadmap guidance for TIPS creation, which improve the accuracy and success rate of portal vein punctures.

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Scorpion Portal Vein Access for TIPS in Portal Hypertension

N/A

Waitlist Available

Led By Venkatesh P. Krishnasamy, MD

Research Sponsored by Argon Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax

≥ 18 years of age at the time of the TIPS procedure

Must not have

Uncorrectable coagulopathy

Active or uncontrolled hepatic encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up index procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing special tools that help doctors connect two veins in the liver more easily during a TIPS procedure. It focuses on patients who need this specific liver treatment to see if these tools can make the process quicker and simpler. TIPS (transjugular intrahepatic portosystemic shunt) is a procedure first performed in 1988, used to treat portal hypertension and variceal bleeding, and has since been improved for wider clinical use.

Who is the study for?

This trial is for adults over 18 needing a TIPS procedure for severe variceal bleeding, ascites, or hydrothorax. Candidates must consent to study rules and follow-ups. Exclusions include polycystic liver disease, active cancer, certain vein conditions or thrombosis, high MELD score (≥18), infections, biliary obstruction, coagulopathy issues, contrast allergies, pregnancy plans in women, uncontrolled hepatic encephalopathy or active bleeding.

What is being tested?

The APASS study evaluates the effectiveness of portal vein access kits used during TIPS procedures which connect the portal and hepatic veins in patients with liver diseases. It compares Scorpion Portal Vein Access Kit with Cook Transjugular Liver Access Set to see which helps better in creating this connection.

What are the potential side effects?

Potential side effects from using these access kits could include discomfort at the insertion site, risk of infection due to invasive nature of procedure; possible allergic reactions to materials used; and complications related to TIPS such as heart strain or worsening encephalopathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a TIPS procedure for severe bleeding, fluid in the abdomen, or fluid around the lungs.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder that cannot be corrected.

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I do not have active or uncontrolled brain issues due to liver disease.

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I have a blockage in my bile ducts.

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I do not have a widespread infection or sepsis.

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I have been diagnosed with polycystic liver disease.

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I have an active cancer diagnosis.

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I do not have a blood clot in the liver veins (Budd-Chiari syndrome).

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I am currently experiencing bleeding from any part of my body.

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I do not have severe heart or lung blood pressure issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of Major Complications

Procedural Success

Secondary study objectives

Device-Related Complications

Fluoroscopy Time

Number of Needle Passes

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: TIPS with Cook Transjugular Liver Access SetActive Control2 Interventions

Ring or Rosch-Uchida access set

Group II: TIPS with Scorpion Portal Vein Access KitActive Control2 Interventions

Scorpion or Scorpion X access set

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver disease include the TIPS procedure, which creates a parenchymal tract between the portal vein and hepatic vein to reduce portal hypertension and prevent complications like variceal bleeding. Other treatments such as TACE and RT target liver tumors, while antiviral therapies aim to eradicate viral infections like HCV and HBV. These treatments are essential as they address both the symptoms and underlying causes of liver disease, thereby improving patient outcomes and quality of life.

Role of band ligation for secondary prophylaxis of variceal bleeding.