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

Primary Purpose

Liver Failure

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

13-C-Methacetin

About this trial

This is an interventional diagnostic trial for Liver Failure focused on measuring 13-C-Methacetin, partial liver resection, liver function tests

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital
Dept. of General- and Visceral Surgery, Jena University Hospital
Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital
Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LiMAx-group

control group

Arm Description

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.

Control group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards.

Outcomes

Primary Outcome Measures

number of correctly determined positive patients in each trial group

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

number of incorrectly determined positive patients in each trial group

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.

sensitivity

number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted negative patients)

specificity

number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted positive patients)

positive predictive value (PPV)

number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted positive patients)

negative predictive value (NPV)

number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted negative patients)

mortality

total mortality until day 30 post-surgical

number of patients with post-surgical liver failure (PHLF)

PHLF according to the Rahbari-Score

total number of complications

total number of complications of grade IIIa (surgical, endoscopic or radiological intervention) to grade V (death)

changes of routine laboratory data

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.

Full Information

NCT ID

NCT01785082

First Posted

January 25, 2013

Last Updated

October 23, 2018

Sponsor

Humedics GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01785082

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 2013 (Actual)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humedics GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Failure

Keywords

13-C-Methacetin, partial liver resection, liver function tests

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LiMAx-group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

No Intervention

Arm Description

Control group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards.

Intervention Type

Drug

Intervention Name(s)

13-C-Methacetin

Intervention Description

intravenous injection of 0.4% 13-C-Methacetin solution, once before partial liver resection, once after partial liver resection

Primary Outcome Measure Information:

Title

number of correctly determined positive patients in each trial group

Description

Time Frame

no later than day 30 after surgery

Secondary Outcome Measure Information:

Title

number of incorrectly determined positive patients in each trial group

Description

Time Frame

no later than day 30 after surgery

Title

sensitivity

Description

number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted negative patients)

Time Frame