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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
149
intravenous injection of 0.4% 13-C-Methacetin solution, once before partial liver resection, once after partial liver resection
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, Germany
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.
Time frame: no later than day 30 after surgery
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.
Time frame: no later than day 30 after surgery
sensitivity
number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted negative patients)
Time frame: 1 year after trial start (anticipated December 2013)
specificity
number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted positive patients)
Time frame: 1 year after trial start (anticipated December 2013)
positive predictive value (PPV)
number of correctly predicted positive patients / (number of correctly predicted positive patients + number of incorrectly predicted positive patients)
Time frame: 1 year after trial start (anticipated December 2013)
negative predictive value (NPV)
number of correctly predicted negative patients / (number of correctly predicted negative patients + number of incorrectly predicted negative patients)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 year after trial start (anticipated December 2013)
mortality
total mortality until day 30 post-surgical
Time frame: 1 year after trial start (anticipated December 2013)
number of patients with post-surgical liver failure (PHLF)
PHLF according to the Rahbari-Score
Time frame: 1 year after trial start (anticipated December 2013)
total number of complications
total number of complications of grade IIIa (surgical, endoscopic or radiological intervention) to grade V (death)
Time frame: 1 year after trial start (anticipated December 2013)
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.
Time frame: until day 30 after surgery