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

Liver Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785082
• Other study ID #: HUM-001
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2018
• Source: Humedics GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The LiMAx-test is compared with an untreated control group and post-surgical management of both groups is investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure

Intervention

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

Locations

Country	Name	City	State
Germany	Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital	Berlin
Germany	Dept. of General- and Visceral Surgery, Jena University Hospital	Jena
Germany	Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital	Leipzig
Germany	Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Humedics GmbH

Country where clinical trial is conducted

Germany, 

References & 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 l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pre- and post-surgical volumetric analysis of the liver	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
Primary	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	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.	no later than day 30 after surgery
Secondary	sensitivity	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)
Secondary	specificity	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)
Secondary	positive predictive value (PPV)	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)
Secondary	negative predictive value (NPV)	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)
Secondary	mortality	total mortality until day 30 post-surgical	1 year after trial start (anticipated December 2013)
Secondary	number of patients with post-surgical liver failure (PHLF)	PHLF according to the Rahbari-Score	1 year after trial start (anticipated December 2013)
Secondary	total number of complications	total number of complications of grade IIIa (surgical, endoscopic or radiological intervention) to grade V (death)	1 year after trial start (anticipated December 2013)
Secondary	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.	until day 30 after surgery

External Links

•   EU clinical trials register with results