Clinical trial NCT01785082: Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Failure
Keywords: 13-C-Methacetin
partial liver resection
liver function tests
Lead sponsor: Humedics GmbH
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: number of correctly determined positive patients in each trial group
timeFrame: no later than day 30 after surgery
Secondary outcomes:
measure: number of incorrectly determined positive patients in each trial group
timeFrame: no later than day 30 after surgery
measure: sensitivity
timeFrame: 1 year after trial start (anticipated December 2013)
measure: specificity
timeFrame: 1 year after trial start (anticipated December 2013)
measure: positive predictive value (PPV)
timeFrame: 1 year after trial start (anticipated December 2013)
measure: negative predictive value (NPV)
timeFrame: 1 year after trial start (anticipated December 2013)
measure: mortality
timeFrame: 1 year after trial start (anticipated December 2013)
measure: number of patients with post-surgical liver failure (PHLF)
timeFrame: 1 year after trial start (anticipated December 2013)
measure: total number of complications
timeFrame: 1 year after trial start (anticipated December 2013)
measure: changes of routine laboratory data
timeFrame: until day 30 after surgery
Other outcomes:
measure: pre- and post-surgical volumetric analysis of the liver
timeFrame: immediately pre and post surgery
Locations:
city: Berlin
country: Germany
facility: Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital
city: Jena
country: Germany
facility: Dept. of General- and Visceral Surgery, Jena University Hospital
city: Leipzig
country: Germany
facility: Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital
city: Würzburg
country: Germany
facility: Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital
Study officials:
affiliation: Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital, Augustenburger Platz 1, 13353 Berlin, Germany
name: Martin Stockmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockmann M, Vondran FWR, Fahrner R, Tautenhahn HM, Mittler J, Bektas H, Malinowski M, Jara M, Klein I, Lock JF; Collaborative Fast-track Liver Study Group. Randomized clinical trial comparing liver resection with and without perioperative assessment of liver function. BJS Open. 2018 Jun 14;2(5):301-309. doi: 10.1002/bjs5.81. eCollection 2018 Sep.