Trial document




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  DRKS00000171

Trial Description

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Title

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

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Trial Acronym

ProNaviC I

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URL of the Trial

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Brief Summary in Lay Language

Tumors of the liver are routinely cut out, perhaps through a so-called keyhole, or killed with heat by a special device. These procedures might profit from new specialized navigation systems tested in pigs but not in men. Our navigation systems use the computed tomography or magnetic resonance tomography of the liver like a three dimensional map. The optimal surgery is computed like one gets directions from the navigation system in a car (GPS). Even though the view of the patient’s liver is updated during surgery, only the surgeon performs the surgery needed. We want to find out how accurately the tumors are removed when navigation systems are used. We hope to thus remove all tumor and as little healthy tissue as possible.

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Brief Summary in Scientific Language

Prospectively documented open multi-center pilot trial to perioperatively evaluate navigation systems in liver tumor surgery (a clinical trial subject to German Medical Device Law)
Three novel specific navigation systems are investigated in separate strata:
A open partial liver resection,
B laparoscopic partial liver resection,
C radio frequency ablation of liver tumors, of patients treated for tumors of the liver.
Surgery is planed using MRI and new software. Planed and realized surgery are compared as accuracy is primary endpoint.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000171
  •   2011/12/08
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  •   yes
  •   Approved
  •   09-201, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1126-1254 
  •   HL1  (Prof. Dr. Hans-Peter Bruch)
  •   5815  (MNO-Nummer)
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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
  •   C22.7 -  Malignant neoplasm: Other specified carcinomas of liver
  •   C22.9 -  Malignant neoplasm: Liver, unspecified
  •   C78.7 -  Secondary malignant neoplasm of liver
  •   D13.4 -  Benign neoplasm: Liver
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Interventions/Observational Groups

  •   stratum A: Open partial liver resection assisted by specialized navigation system based on segmentation software applied to MRI.
  •   stratum B: Laparoscopic partial liver resection assisted by specialized navigation system based on segmentation software applied to MRI.
  •   stratum C: Transcutaneous radio frequency ablation of liver tumors assisted by specialized navigation system based on segmentation software applied to MRI.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2011/12/14
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
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Additional 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.

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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.


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Addresses

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    • Universitätsklinikum Schleswig-Holstein-Campus Lübeck Klinik für Chirurgie
    • Mr.  Prof. Dr. med.  Hans-Peter  Bruch 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein-Campus Lübeck Klinik für Chirurgie
    • Mr.  Dr. med.  Markus  Kleemann 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universitätsklinikum Schleswig-Holstein-Campus Lübeck Klinik für Chirurgie
    • Mr.  Dr. med.  Markus  Kleemann 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannnstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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