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 rebro 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.
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.
| Condition | Oral Neoplasm, Head and Neck Cancer, head and neck cancer, Oral Cavity Cancer, oral cancers, Oral Cancer |
|---|---|
| Clinical Study Identifier | NCT04398121 |
| Sponsor | Region Örebro County |
| Last Modified on | 30 June 2022 |
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Congrats! You have your own personal workspace now.