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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)

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010663
Enrollment
100
Registered
2016-07-12
Start date
2019-01-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C20 C22 C18 C19

Interventions

Group 1: Arm 1: Micro Plug (KA Medical Micro Plug Set). The RE is performed as a minimally invasive, angiographic procedures without anesthesia. The vessel closure by micro plug is carried out by cath

Sponsors

Otto-von-Gueriocke Universität, Medizinsiche Fakultät
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Safety and effectiveness of MicroPlug embolization compared to the coil embolization (macro plug) of the gastroduodenal artery during the evaluation of the liver Radioembolization 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

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

Countries

Germany

Contacts

Public ContactMaciej Pech

Universitätsklinik für Radiologie und Nuklearmedizin

maciej.pech@med.ovgu.de+49-391-67-15634

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026