Prospective, randomized 2-arm trial evaluating the clinical safety and feasibility in patients for embolization of the gastroduodenal artery and artery gastric artery with MicroPlug CE Certificate (MP) for comparison with platinum-fibered Microcoils before Radioembolization (SIRT)

Not Applicable

Conditions: C20
C22
C18
C19
Malignant neoplasm of rectum
Malignant neoplasm of liver and intrahepatic bile ducts
Malignant neoplasm of colon
Malignant neoplasm of rectosigmoid junction

Registration Number: DRKS00010663

Lead Sponsor: Otto-von-Gueriocke Universität, Medizinsiche Fakultät

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: All

Target Recruitment: 100

Inclusion Criteria

Consent from the patient
• HCC or secondary hepatic metastatic carcinoma
• Indication for RE (SIRT) in one or two sessions
• male or female,> 18 years
• Approval of all study procedures participate

Exclusion Criteria

• Contraindication radioembolization liver
• Contraindications for vascular embolization (for example, retrograde flow of the gastroduodenal artery at Tr. Celiac stenosis)
• Whipple procedure with resection / ligation of the gastroduodenal artery
• Billroth surgical resection of gastric artery
• diameter of the gastroduodenal artery> 4.5 mm in the planning CTA
• Contraindications to angiography, X-ray contrast medium CT
• Known allergy to nickel

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and effectiveness of MicroPlug embolization compared to the coil embolization (macro plug) of the gastroduodenal artery during the evaluation of the liver Radioembolization<br><br>The security checks by an unraised complication in the experimental group. The effectiveness is studied by means of a sufficient embolization without reperfusion in the angiographic control during therapy.

Secondary Outcome Measures

Name	Time	Method
1.The safety and effectiveness of the micro plug-embolization compared to<br>the coil embolization (macro plug) of the right gastric artery during the evaluation of a liver<br>radioembolization.<br><br>2. Descriptive analysis reviewed:<br>- The whole procedure time,<br>- The fluoroscopy time,<br>- The pure embolization time,<br>- Number of embolization materials used,<br>- Volume of the contrast agent used, <br>- frequency of embolic-related complications,<br>- the reperfusion of embolized vessels in a two-armed cohort