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

October 23, 2018 updated by: Humedics GmbH

Prospective, Randomized, Controlled, Multi-centric, Phase III Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital
      • Jena, Germany, 07747
        • Dept. of General- and Visceral Surgery, Jena University Hospital
      • Leipzig, Germany, 04103
        • Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital
      • Würzburg, Germany, 97080
        • Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
no later than day 30 after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
no later than day 30 after surgery
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)
1 year after trial start (anticipated December 2013)
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)
1 year after trial start (anticipated December 2013)
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)
1 year after trial start (anticipated December 2013)
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)
1 year after trial start (anticipated December 2013)
mortality
Time Frame: 1 year after trial start (anticipated December 2013)
total mortality until day 30 post-surgical
1 year after trial start (anticipated December 2013)
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
1 year after trial start (anticipated December 2013)
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)
1 year after trial start (anticipated December 2013)
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.
until day 30 after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
immediately pre and post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Humedics GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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