In last decades, ultrasound probes have become smaller, which made adequate intraoral ultrasound of oral tumors possible. Therefore, invasion depth is now determined pre-operatively by intraoral ultrasound for staging of oral cancer. Our feasibility…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
resection margin control
Secondary outcome
amount of re-resections or postoperative irradiation.
Background summary
Squamous cell carcinoma of the tongue and buccal mucosa is preferably treated
by surgery. Its complete removal is essential for locoregional control and
disease-free survival. Inadequate resection margins require adjuvant therapy
such as re-resection or (chemo)radiation, which causes extra morbidity.
Unfortunately, resection margins in tongue and buccal mucosa cancer are often
inadequate and the main indication to apply adjuvant treatment in these
patients. A retrospective analysis of surgically treated patients with tongue
and buccal mucosa squamous cell carcinoma in our centre revealed 51-70% close
margins and 15-24% positive margins in our center. Especially deep resection
margins often appeared close or positive. These results are in line with
literature, that reports 42-48% close resection margins and even 28-36%
positive resection margins in oral cancers. Adjuvant treatment at the primary
tumor site was given to 31-35% of our patients with oral cancer (re-resections
or radiotherapy) which could have been prevented by better margin control.
Adjuvant treatment (especially irradiation) after inadequate resection may
affect the quality of life of our patients due to significant morbidity and
(oral) discomfort, including xerostomia, mucositis, fibrosis and
osteoradionecrosis. To reduce morbidity in patients with tongue and buccal
mucosa cancer, better control of submucosal and deep resection margins is
pivotal.
Study objective
In last decades, ultrasound probes have become smaller, which made adequate
intraoral ultrasound of oral tumors possible. Therefore, invasion depth is now
determined pre-operatively by intraoral ultrasound for staging of oral cancer.
Our feasibility study of ultrasound guided resection of tongue cancer revealed
a improvement of margin control without resection of an excessive amount of
healthy tissue.
Objective
We aim to use intraoral ultrasound during resection of tongue and buccal mucosa
squamous cell carcinomas to limit the amount of close and positive resection
margins and reduce the amount of re-resections or postoperative irradiation and
thereby reduce morbidity to eventually improve the quality of life of our
patients.
Study design
1. A feasibilty study to optimize the protocol and built experience (learning
curve) with imaging guided surgery for early tongue cancers using intraoral
ultrasound. (10 patients), finished in February 2020,
2. A pilot study in tongue cancer to investigate if ultrasound guided resection
improves margin control (30 patients)
3. A pilot study in buccal mucosa cancer to investigate if ultrasound guided
resection improves margin control (25 patients)
Intervention
ultrasound guided resection of tongue or buccal mucosa cancer.
Study burden and risks
Burden and risks are minimal, since ultrasound are a non-invasive form of
imaging.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
tongue cancer or buccal mucosa cancer with indication of surgical resection
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL69038.041.19 |