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Liver FailurePhase 3NCT01785082

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

A Phase 3 study testing 13-C-Methacetin in people with Liver Failure, run by Humedics GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Failure
What is being tested?
13-C-Methacetin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
4 sitesGermany
Study dates
Jan 2013to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

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

    Berlin, 13353

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

    Jena, 07747

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

    Leipzig, 04103

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

    Würzburg, 97080

Other trials in Germany

About this study

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

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.

Conditions
Liver Failure
Being tested
13-C-Methacetin
Keywords
13-C-Methacetin, partial liver resection, liver function tests
Medical subject headings
Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13-C-MethacetinDrug

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

Study groups in NCT01785082
Study groupRoleWhat they receive
LiMAx-groupExperimentalIntravenous 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.
Receives: Drug: 13-C-Methacetin
control groupNo interventionControl group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: no later than day 30 after surgery

Secondary outcomes (9)

  1. 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.

    Measured: no later than day 30 after surgery

  2. sensitivity

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

    Measured: 1 year after trial start (anticipated December 2013)

  3. specificity

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

    Measured: 1 year after trial start (anticipated December 2013)

  4. positive predictive value (PPV)

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

    Measured: 1 year after trial start (anticipated December 2013)

  5. negative predictive value (NPV)

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

    Measured: 1 year after trial start (anticipated December 2013)

  6. mortality

    total mortality until day 30 post-surgical

    Measured: 1 year after trial start (anticipated December 2013)

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

    PHLF according to the Rahbari-Score

    Measured: 1 year after trial start (anticipated December 2013)

  8. total number of complications

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

    Measured: 1 year after trial start (anticipated December 2013)

  9. 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.

    Measured: until day 30 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01785082
Sponsor's protocol ID
HUM-001
Status last verified
Oct 2018
First submitted
25 Jan 2013
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30263981

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-C-Methacetin in people with Liver Failure, run by Humedics GmbH at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of correctly determined positive patients in each trial group (time frame: no later than day 30 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01785082, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.

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