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

NCT01785082 | Completed Phase 3

• 1 other identifier: HUM-001
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 4

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.

Conditions

Liver Failure

Keywords

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

Outcome Measures

Primary Outcomes (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.

  no later than day 30 after surgery

Secondary Outcomes (9)

• number of incorrectly determined positive patients in each trial group

  no later than day 30 after surgery

• sensitivity

  1 year after trial start (anticipated December 2013)

• specificity

  1 year after trial start (anticipated December 2013)

• positive predictive value (PPV)

  1 year after trial start (anticipated December 2013)

• negative predictive value (NPV)

  1 year after trial start (anticipated December 2013)

Other Outcomes (1)

• pre- and post-surgical volumetric analysis of the liver

  immediately pre and post surgery

Study Arms (2)

LiMAx-group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

13-C-Methacetin DRUG

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

LiMAx-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• at screening:
• anamnestic known hypersensitivity against one of the study drugs, their ingredients or drugs with chemically similar structure (in particular paracetamol)
• patients with previous liver surgery (OPS-Code 5-502), including biliodigestive anastomosis, excluding cholecystectomy.
• 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

Sponsors & Collaborators

• Humedics GmbH: lead

Study Sites (4)

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

Berlin, 13353, Germany

Location

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

Jena, 07747, Germany

Location

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

Leipzig, 04103, Germany

Location

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

Würzburg, 97080, Germany

Location

Related Publications (1)

• 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.

  PMID: 30263981 RESULT

Related Links

• EU clinical trials register with results

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Martin Stockmann, PD Dr. med.

  Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital, Augustenburger Platz 1, 13353 Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

DE (4)