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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| control group | No Intervention | Control group without intervention. Post-surgical management as defined prior to surgery following well-established clinical standards. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-C-Methacetin | Drug | intravenous injection of 0.4% 13-C-Methacetin solution, once before partial liver resection, once after partial liver resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
at screening:
at visit 2:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Stockmann, PD Dr. med. | Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital, Augustenburger Platz 1, 13353 Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital | Berlin | 13353 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30263981 | Result | 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. |
| Label | URL |
|---|---|
| EU clinical trials register with results | View source |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| 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) |
| 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) |
| 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) |
| 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) |
| mortality | total mortality until day 30 post-surgical | 1 year after trial start (anticipated December 2013) |
| number of patients with post-surgical liver failure (PHLF) | PHLF according to the Rahbari-Score | 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) | 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. | until day 30 after surgery |
| Dept. of General- and Visceral Surgery, Jena University Hospital |
| Jena |
| 07747 |
| Germany |
| Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital | Leipzig | 04103 | Germany |
| Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital | Würzburg | 97080 | Germany |