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
May 2022
Primary Completion Date
May 2022
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
August 2021