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

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ClinicalTrials.gov Identifier: NCT01785082
Recruitment Status : Unknown
Verified October 2013 by Humedics GmbH.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Humedics GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Failure Drug: 13-C-Methacetin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective, Randomized, Controlled, Multi-centric, Phase III Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
Study Start Date : January 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : May 2014

Arm Intervention/treatment
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.
Drug: 13-C-Methacetin
intravenous injection of 0.4% 13-C-Methacetin solution, once before partial liver resection, once after partial liver resection

No Intervention: control group
Control group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards.



Primary Outcome Measures :
  1. number of correctly determined positive patients in each trial group [ Time Frame: no later than day 30 after surgery ]
    Correctly determined positive patients are patients which are transferred to general ward after surgery because of the result of the LiMAx-test (LiMAx-group) or general diagnosis (control group). Patients have to stay at general ward until discharge no later than day 30 after surgery.


Secondary Outcome Measures :
  1. number of incorrectly determined positive patients in each trial group [ Time Frame: no later than day 30 after surgery ]
    Incorrectly determined positive patients are patients which are transferred to general ward after surgery because of the result of the LiMAx-test or general diagnosis (control group) and do not stay at general ward until discharge or are discharged later than 30 days after surgery.

  2. sensitivity [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted negative patients)

  3. specificity [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted positive patients)

  4. positive predictive value (PPV) [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted positive patients)

  5. negative predictive value (NPV) [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted negative patients)

  6. mortality [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    total mortality until day 30 post-surgical

  7. number of patients with post-surgical liver failure (PHLF) [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    PHLF according to the Rahbari-Score

  8. total number of complications [ Time Frame: 1 year after trial start (anticipated December 2013) ]
    total number of complications of grade IIIa (surgical, endoscopic or radiological intervention) to grade V (death)

  9. changes of routine laboratory data [ Time Frame: until day 30 after surgery ]
    assessment of clinical data (sodium, potassium, creatinine, urea, protein, albumin, total bilirubin, AST, ALT, AP, GGT, blood count, INR, PTT). In addition, clinical data as pulse or blood pressure are recorded.


Other Outcome Measures:
  1. pre- and post-surgical volumetric analysis of the liver [ Time Frame: immediately pre and post surgery ]
    Pre-surgical volumetric analysis of liver and tumor by CT or MRT and post-surgical volumetric analysis of the resected liver.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

at screening:

  • anamnestic known hypersensitivity against one of the study drugs, their ingredients or drugs 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 biliodigestive anastomosis, excluding cholecystectomy.
  • patients which underwent interventions such as radiofrequency ablation, biopsies or smaller surgeries within 6 weeks before inclusion
  • patients anticipated for biliodigestive anastomosis and/or suffering from a Klatskin-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 interventional technique (e.g. radio frequency ablation RFA, embolization)
  • patients which are intended to simultaneously get a surgery on other organs (excluding cholecystectomy)
  • patients which are intended to simultaneously get a vascular anastomosis (e.g. portal vein 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 inflammatory diseases (e.g. autoimmune hepatitis, Morbus Crohn, colitis ulcerativa)
  • patients with severe cardiovascular diseases and/or severe diseases of the respiratory system which receive intensive care in any case (e.g. heart surgery, bypass surgery, cardiac valve replacement, unstable angina pectoris, severe coronary heart disease with intervention during the last 6 months, severe COPD (chronic obstructive pulmonary disease), 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 implications because 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 commitment to be sexually inactive until day 30 after surgery or discharge; postmenopause (12 months of natural occurring amenorrhoea); at least 6 weeks after ovariectomy with or without hysterectomy

at visit 2:

  • patients anticipated for laparoscopic partial liver resection
  • patients which are intended to be simultaneously treated with an interventional technique (e.g. radio frequency ablation RFA, embolization)
  • patients which are intended to simultaneously get a surgery on other organs (excluding cholecystectomy)
  • patients which are intended to simultaneously get a vascular anastomosis (e.g. portal vein 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 respiratory system which receive intensive care in any case (e.g. heart surgery, bypass surgery, cardiac valve replacement, unstable angina pectoris, severe coronary heart disease with intervention during the last 6 months, severe COPD (chronic obstructive pulmonary disease), severe asthma with concomitant cortisone medication)
  • patients anticipated for biliodigestive anastomosis and/or suffering from a Klatskin-tumor
  • patients with a ASA (American Society of Anesthesiologists) classification >3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785082


Contacts
Contact: Brigitte Hoch, Dr. +49-30-590083249 brigitte.hoch@humedics.de

Locations
Germany
Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital Recruiting
Berlin, Germany, 13353
Contact: Martin Stockmann, PD Dr. med.    +49-30-450552001    martin.stockmann@charite.de   
Principal Investigator: Martin Stockmann, PD Dr. med.         
Sub-Investigator: Gerhard Hunold, Dr.         
Sub-Investigator: Maximilian Jara         
Sub-Investigator: Maciej Malinowski, Dr.         
Sub-Investigator: Sascha Chopra, Dr.         
Dept. of General- and Visceral Surgery, Jena University Hospital Recruiting
Jena, Germany, 07747
Contact: Utz Settmacher, Prof. Dr.    +49-36419322601    utz.settmacher@med.uni-jena.de   
Principal Investigator: Utz Settmacher, Prof. Dr.         
Sub-Investigator: Alen Nikolic, Dr.         
Sub-Investigator: Astrid Bauschke, Dr.         
Sub-Investigator: Rene Fahrner, Dr.         
Sub-Investigator: Alexander Koch         
Sub-Investigator: Vyron Mategakis         
Sub-Investigator: Lawrence Mutwol, Dr.         
Sub-Investigator: Falk Rauchfuß, Dr.         
Sub-Investigator: Hubert Scheuerlein, Dr.         
Sub-Investigator: Ulrike Schöne, Dr.         
Sub-Investigator: Frank Uteß         
Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital Recruiting
Leipzig, Germany, 04103
Contact: Hans-Michael Tautenhahn    0341-9717185    hans-michael.tautenhahn@medizin.uni-leipzig.de   
Principal Investigator: Hans-Michael Tautenhahn         
Sub-Investigator: Michael Bartels, Dr.         
Sub-Investigator: Georgi Atanasov         
Sub-Investigator: Christian Benzing         
Sub-Investigator: Julian Bucher, Dr.         
Sub-Investigator: Moritz Schmelzle, Dr.         
Sub-Investigator: Markus Schoenberg, Dr.         
Sub-Investigator: Katrin Semmling         
Sub-Investigator: Georg Wiltberger, Dr.         
Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital Recruiting
Würzburg, Germany, 97080
Contact: Johan F. Lock, Dr.    0931-20131181    Lock_J@chirurgie.uni-wuerzburg.de   
Principal Investigator: Johan F. Lock, Dr.         
Sub-Investigator: Ingo Klein, Prof.         
Sub-Investigator: Klaus-Ulrich Steger, Dr.         
Sponsors and Collaborators
Humedics GmbH
Investigators
Principal Investigator: Martin Stockmann, PD Dr. med. Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital, Augustenburger Platz 1, 13353 Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Humedics GmbH
ClinicalTrials.gov Identifier: NCT01785082     History of Changes
Other Study ID Numbers: HUM-001
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013

Keywords provided by Humedics GmbH:
13-C-Methacetin
partial liver resection
liver function tests

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics