Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test

Last updated: October 23, 2018
Sponsor: Humedics GmbH
Overall Status: Completed

Phase

3

Condition

Liver Disease

Liver Failure

Treatment

N/A

Clinical Study ID

NCT01785082
HUM-001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • male or female patients of 18 years or older which are able to give informed consentwith indication for surgical partial liver resection according to OPS code 5-502; thisincludes benign and malign tumors.

  • patients with pre-surgical thin-layer CT or MRT of the liver not older than 6 weeks orpatients where a pre-surgical thin-layer CT or MRT of the liver is planned beforesurgery.

  • written informed consent

Exclusion

Exclusion Criteria: at screening:

  • anamnestic known hypersensitivity against one of the study drugs, their ingredients ordrugs with chemically similar structure (in particular paracetamol)

  • participation in another clinical trials within 4 weeks before inclusion

  • patients with previous liver surgery (OPS-Code 5-502), including biliodigestiveanastomosis, excluding cholecystectomy.

  • patients which underwent interventions such as radiofrequency ablation, biopsies orsmaller surgeries within 6 weeks before inclusion

  • patients anticipated for biliodigestive anastomosis and/or suffering from aKlatskin-tumor

  • patients with a ASA (American Society of Anesthesiologists) classification >3

  • patients anticipated for laparoscopic partial liver resection

  • patients which are intended to be simultaneously treated with an interventionaltechnique (e.g. radio frequency ablation RFA, embolization)

  • patients which are intended to simultaneously get a surgery on other organs (excludingcholecystectomy)

  • patients which are intended to simultaneously get a vascular anastomosis (e.g. portalvein resection)

  • patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)

  • patients with congenital metabolic diseases, in particular hepatic storage diseases

  • hepatic infection with Echinococcus multilocularis

  • patients with known non-infectious, auto-immune conditioned chronic inflammatorydiseases (e.g. autoimmune hepatitis, Morbus Crohn, colitis ulcerativa)

  • patients with severe cardiovascular diseases and/or severe diseases of the respiratorysystem which receive intensive care in any case (e.g. heart surgery, bypass surgery,cardiac valve replacement, unstable angina pectoris, severe coronary heart diseasewith intervention during the last 6 months, severe COPD (chronic obstructive pulmonarydisease), severe asthma with concomitant cortisone medication)

  • patients with severe bacterial infection at screening

  • patients with known immunodeficiency

  • heavy smokers (>20 cigarettes a day)

  • patients which are unable to understand the study and its possible implicationsbecause of addiction or other diseases

  • patients who are suspected not to cooperate or to comply to the trial protocol

  • patients accommodated in an institution due to public or legal authority

  • pregnant or lactating women

  • women with child-bearing potential, excluding: negative pregnancy test and commitmentto be sexually inactive until day 30 after surgery or discharge; postmenopause (12months of natural occurring amenorrhoea); at least 6 weeks after ovariectomy with orwithout hysterectomy at visit 2:

  • patients anticipated for laparoscopic partial liver resection

  • patients which are intended to be simultaneously treated with an interventionaltechnique (e.g. radio frequency ablation RFA, embolization)

  • patients which are intended to simultaneously get a surgery on other organs (excludingcholecystectomy)

  • patients which are intended to simultaneously get a vascular anastomosis (e.g. portalvein resection)

  • patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)

  • hepatic infection with Echinococcus multilocularis

  • patients with severe cardiovascular diseases and/or severe diseases of the respiratorysystem which receive intensive care in any case (e.g. heart surgery, bypass surgery,cardiac valve replacement, unstable angina pectoris, severe coronary heart diseasewith intervention during the last 6 months, severe COPD (chronic obstructive pulmonarydisease), severe asthma with concomitant cortisone medication)

  • patients anticipated for biliodigestive anastomosis and/or suffering from aKlatskin-tumor

  • patients with a ASA (American Society of Anesthesiologists) classification >3

Study Design

Total Participants: 149
Study Start date:
January 01, 2013
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • Dept. of General-, Visceral- and Graft Surgery, Aachen University Hospital

    Aachen, 52074
    Germany

    Site Not Available

  • Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital

    Berlin, 13353
    Germany

    Site Not Available

  • Dept. of General- and Visceral Surgery, Jena University Hospital

    Jena, 07747
    Germany

    Site Not Available

  • Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital

    Leipzig, 04103
    Germany

    Site Not Available

  • Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital

    Würzburg, 97080
    Germany

    Site Not Available

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