Prospective, Randomized, Controlled, Multi-centric, Phase III Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
Status: Completed
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection. The LiMAx-test is compared with an untreated control group and post-surgical management of both groups is investigated.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• male or female patients of 18 years or older which are able to give informed consent with indication for surgical partial liver resection according to OPS code 5-502; this includes benign and malign tumors.
• patients with pre-surgical thin-layer CT or MRT of the liver not older than 6 weeks or patients where a pre-surgical thin-layer CT or MRT of the liver is planned before surgery.
• written informed consent
Locations
Other Locations
Germany
Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital
Berlin
Dept. of General- and Visceral Surgery, Jena University Hospital
Jena
Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital
Leipzig
Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital
Würzburg
Time Frame
Start Date:2013-01
Completion Date:2015-09
Participants
Target number of participants:149
Treatments
Experimental: LiMAx-group
Intravenous pre- and post-surgical injection of 0.4% 13-C-Methacetin solution. Dosage is adapted due to body weight (2 mg/kg). A LiMAx-test of \>150 µg/kg/h would correspond to a general ward indication.
No_intervention: control group
Control group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards.