NBI in Oral Cavity Cancer

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Brief Title

NBI in Oral Cavity Cancer

Official Title

Narrow Band Imaging in Oral Cavity Cancer-defining the Tumour Border

Brief Summary

      Oral cancer starts in the mucosa of the mouth and the most common site is the tongue and
      gingiva. One of the most important issues for the prognosis is to surgically remove all the
      cancer, at the sides as well as at the deep margin. To accomplish that, it is crucial to
      identify the border between tumour and healthy tissue. Traditionally white light from a head
      light or operation theatre lamp is used to illuminate the area of the tumour. Narrow Band
      Imaging (NBI) is an optical technique where ordinary white light is filtered so only the blue
      light in it is used. Illuminating the mucosa with this blue light through an endoscope with
      high definition image, makes the blood vessels appear more clearly. The altered blood vessels
      that the cancer produce can thereby be seen and mark the area where the tumour starts.

      This study examines if NBI is helpful in the decision of where the border between the cancer
      and the normal mucosa is. If so, NBI might improve the possibility to remove all cancer
      tissue compared to using the ordinary white light.

      This study will also increase the knowledge about the NBI technique, which is helpful in the
      examination of patients with suspected head and neck cancers and at the follow-up of patients
      after treatment.

      Participants are patients with oral cancer presenting at the otorhinolaryngology department
      in Örebro University hospital in Sweden for surgical treatment. The surgery will be done in
      the usual fashion but the mucosa surrounding the tumour will also be illuminated by NBI and
      this picture of the vessels will be compared to the microscopic analysis by the pathologist,
      the so called PAD. Thereby we seek to compare the border in white light to the border seen
      with NBI.
    

Detailed Description

      Patients with primary oral cavity cancer will be examined with Narrow Band Imaging (NBI) at
      the time of surgery. Olympus® equipment will be used together with straight 5,9 mm
      endoscopes.

      First the tumour border seen in white light will be defined. Thereafter endoscopic
      examination with white light and NBI will be performed and recorded. Then the tumour border
      seen in white light will be marked with dots by monopolar diathermy. Finally the area is
      examined again with NBI and if the tumour border is seen outside the border seen in white
      light, that area is marked by a suture for the pathology report.

      Since the purpose of this study is to gain knowledge of NBI in oral cavity cancer, the
      resection margin will be marked at least 10mm from the tumour border as it is seen in white
      light in the ordinary fashion. However there are evolving evidence that NBI better delineate
      tumour border in larynx and some data for the oral cavity, therefore any suspected mucosa
      according to NBI outside the ordinary resection margin will be included with a small margin.

      There is no uniform definition of the NBI pattern in oral cavity cancer. The planned criteria
      is changed IPCL type III/IV according to Takano (see ref.) and so called "marked brown dots"
      as criteria for precancerous or cancerous mucosa according to NBI.

      The tumour border in white light and NBI will be compared and PAD is considered gold
      standard.

      To reach 80% power with 5 % type 1 error, two-sided test, and 25% of the examinations
      anticipated to show different tumour border with NBI, 49 participants will be needed.
    


Study Type

Observational


Primary Outcome

NBI tumour border


Condition

Oral Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

54

Start Date

August 13, 2020

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

        Biopsy proven squamous cell carcinomaI. International Statistical Classification of
        Diseases and Related Health Problems (ICD) 10 C02-C06.

        Exclusion Criteria:

          -  former extensive surgery in the oral cavity that effects the examination

          -  former radiation to the oral cavity

          -  patients not suitable for surgery
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Johan Knutsson, Assoc. Prof., +46(0)196021000, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04398121

Organization ID

273124


Responsible Party

Sponsor

Study Sponsor

Region Örebro County


Study Sponsor

Johan Knutsson, Assoc. Prof., Principal Investigator, Region Örebro County


Verification Date

May 2020