Prospectively documented multicenter pilot trial to perioperatively evaluate navigation systems in liver tumor surgery (a clinical trial subject to German Medical Devices Law)

Not Applicable

• Conditions: C22.0; C22.1; C22.7; C22.9; C78.7; D13.4; Liver cell carcinoma; Intrahepatic bile duct carcinoma; Other specified carcinomas of liver; Liver, unspecified

• Registration Number: DRKS00000171
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein-Campus LübeckKlinik für Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

statum A – Liver Surgery Assistance System:
-male and female patients, scheduled for partial resection of the liver because of liver tumors,
-presence of MRI of the liver performed less than 4 weeks ago,
-age > 50 years
-written informed consent by patient,
-Patient must be EU citizen.
stratum B – LapAssistant:
-male or female patients scheduled for a partial resection of the liver because of benign or malign tumors
-presence of MRI of the liver performed less than 4 weeks prior to surgery
-age > 18 years
-written informed consent by patient
-Patient must be EU citizen.
stratum C – Interventional Assistant for transcutaneous RFA:
-malign hepatocellular carcinoma or metastases confirmed on histology, which are not operable, up to a maximum diameter of 5 cm or up to 5 lesions with maximum diameter of 3 cm or less.
-written informed consent by patient
- Tumor is inoperable by tumor board review or patient declines surgery.
-Patient must be EU citizen.

Exclusion Criteria

stratum A – Liver Surgery Assistance System:
- patient with previous liver surgery (cholecystectomy is no exclusion criterion), -patients with severe infectious disease, -Patients with established renal insufficiency (defined as elevated serum creatinine level), -patients with intolerance of contrast media, -patients with latent or manifest hyperthyreosis (defined as decreased basal TSH level), - all factors limiting the patient’s ability to cooperate (e.g. mental condition or drug abuse), - pregnant or breast feeding female patients, - patients with contraindication to MRI.
stratum B – LapAssistant:
- patient with previous liver surgery (cholecystectomy is no exclusion criterion), - patients with severe infectious diseases, -Patients with established renal insufficiency (defined as elevated serum creatinine level), -patients with intolerance of contrast media, -patients with latent or manifest hyperthyreosis (defined as decreased basal TSH level), - all factors limiting the patient’s ability to cooperate (e.g. mental condition or drug abuse), - pregnant or breast feeding female patients, - patients with contraindication to MRI, - patients with pacemaker.
stratum C – Interventional Assistant for transcutaneous RFA:
- Patients younger than 18 years or older than 80 years.
-limited blood coagulation: prothrombin time < 50 %, partial thromboplastin time > 50 sec. platelet count below 50,000 per microlitre, bleeding time > 7 min.
-central tumor location: close adjacency to one of the three major hepatic vein branches or right or left branch of the portal vein ,
-extrahepatic manifestation of HCC,
-Pregnant or breast feeding female patients are excluded.
- patients with severe infectious diseases,
-all factors limiting the patient’s ability to cooperate (e.g. mental condition or drug abuse),
-patients with contraindication to MRI.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: frequency, severity, and causality of complications. Function: planning precision. First primary endpoint is the ratio of real volume of the remaining liver with undisturbed perfusion at the second postoperative day to the planned volume of the remaining liver based on the 3-D-reconstructions in strata A and B and the similarly measured ratio of planned and realized ablation volume in stratum C.

Secondary Outcome Measures

Name	Time	Method
R0 resection, duration of surgery, recurrence free survival, complications, AE, and quality of life by EORTC QLQ C30 version 3.0 LM C21 prior to surgery, at discharge, after 6 months and after 12 months.