Trial document

This trial has been registered retrospectively.
drksid header


Trial Description

start of 1:1-Block title


Visualization of tumor resection margins for planning of radiation treatment in head & neck cancer surgery

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Communication between the surgeon, the pathologist and the radiation oncologist is improved by a virtual model of the final resection combining 3D imaging with computer aided navigation. The pathologist localises any questionable margins and the oncologist plans focussed delivery of radiation to native tissue in an area of complex anatomy.
We present here with the help of a case, a technique using 3 dimensional imaging, computer aided navigation and conventional tissue marking with titanium clips to aid in standardized interdisciplinary communication and in the planning of focussed adjuvant irradiation. Further clinical studies are needed to determine any outcome benefit from this focussed radiotherapy if the additional time and cost are to be justified.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Cancer of the head and neck requires a multidisciplinary approach. Given the involvement of mutliple disciplines, precise communication is indispensable and a challenge. Optimisation of patient management has been promoted by the setting up of multidisciplnary teams (MDT) or “tumour boards” that discuss various options and drawbacks.
The anatomy of the head and neck offers a further challenge in the management of these patients where a balance between complete resection and organ preservation with good postoperative function and quality of life is often difficult.
Once a decision for surgery is made, the next important step is precise communication between the surgeon and the pathologist regarding specimen orientation and location of any additional biopsies or frozen section specimens. The desired goal in cancer surgery is cure for which a complete resection (R0 Resection) of the malignant neoplasm is a starting point. Patients with positive or close surgical margins (R1 Resection) show a significantly poorer outcome.
It is becoming more common to send frozen section biopsies intraoperatively. The method of labelling these are individual to the surgeon. The processing pathologist receives a specimen and a lable with a minimal idea of its orientation. From this a response of positive or negative is sought. If positive it falls upon the memory of the surgeon to localise where the sample was precisely taken which will ultimately affect the final resection margin.
When there is neck lymphnode involvement, T3-4 tumors or R1-Rx tumor resection, guidelines suggest patients should receive adjuvant radiotherapy. The radiation oncologist requires as much information as possible from the surgeon and pathologist to plan delivery radiation dose to affected tissue and to minimize unnecessary radiation of adjacent tissues and vital structures. Traditionally the oncologist bases the treatment plan on printed pathology reports and preoperative and postoperative imaging with possible assistance from surgical notes which are notoriously indecipherable.
In recent years the use of computer-assisted-surgery (CAS) has been established in many surgical disciplines. This allows three-dimensional surgical planning with visualization of tumour extent and possible resection margins. Intra-operatively, CAS procedures enable fairly precise three-dimensional anatomical orientation with more defined localization of resection boundaries.
Following resection the defect is often reconstructed with free vascularised tissue. If adjuvant irradiation is then advised, it is challenging for the oncologist to plan radiotherapy focussed on the resection margins and native tissue while sparing the tumour free vascularised graft. It is well known that wound healing after tissue reconstruction is reduced by post-operative radiation. On the other side, an increase of the irradiation dose correlats with an increase of the tumor controle. Precise orientation of the boundaries between resection margin and free flap reconstruction therefore becomes important. Planning radiotherapy is further complicated by variation between the virtual resection margin and the true post-surgical one. Additionally soft tissue shifts as the result of gravity and swelling will alter the appearance of the resection margins. In order to avoid this traditional the margins are marked with titanium ligature clips.
We describe a technique where we combine preoperative 3D imaging and intraoperative navigation with conventional marking to produce a precise delineation of the tumour margin to aid in communication with the pathologist and to help the radiation oncologist in the planning and delivery of adjuvant radiotherapy.
In addition, the clips and navigation points and a possible tumor relaps should be evaluated.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007534
  •   2014/12/04
  •   [---]*
  •   yes
  •   Approved
  •   463/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C31 -  Malignant neoplasm of accessory sinuses
  •   C00 -  Malignant neoplasm of lip
  •   C01 -  Malignant neoplasm of base of tongue
  •   C03 -  Malignant neoplasm of gum
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   marking of tumor resection margins after complete tumor removal with 6 titanium clips (Ethicon Endo-Surgery, Ligaclip Extra Titanium Medium) and the intro-operative navigation,
    postoperative routine CT imaging,
    image fusion of preoperative and postoperative datasets
    Evaluation of the clips and the navigation points, delineation of the tumor resection margin
    Transmission of data to the radiation oncologist and planning of adjuvant radiotherapy
    Determination of the clip movement in function of the time
    Comparison clip and navigated points
    regular routine CT examination in the course,
    Repetition of the evaluation points
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Occurrence of a relapse to tumor after finished of radiotherapy, control by routine CT examination

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

overal survival

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2012/12/01
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

oral squamous cell carcinoma and planned adjuvant radiation therapy

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

primary radiochemotherapy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Departement für Mund Kiefer Gesichtschirurgie
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0049 761 270 47010
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Uniklinik Freiburg, MKG
    • Mr.  Dr. Dr.  Gido  Bittermann 
    • Higstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik Freiburg, MKG
    • Mr.  Dr. Dr.  Gido  Bittermann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Department of Oral and Maxillofacial Surgery
    • Mr.  Prof. Dr. Dr.  Schmelzeisen 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.