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Buccal Cancer Resection Ultrasound Guided

Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05852665
Acronym
BRUG
Enrollment
50
Registered
2023-05-10
Start date
2023-09-01
Completion date
2026-03-01
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Buccal Mucosa Cancer, Squamous Cell Carcinoma

Keywords

Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter

Brief summary

The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

Detailed description

Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (\<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt. The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life. In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection. 50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.

Interventions

DEVICEUltrasound-guided resection

Ultrasound-guided resection of buccal squamous cell carcinomas

Sponsors

Rijnstate Hospital
CollaboratorOTHER
University Medical Center Groningen
CollaboratorOTHER
Medisch Spectrum Twente
CollaboratorOTHER
Medical Center Haaglanden
CollaboratorOTHER
Antoni van Leeuwenhoek Ziekenhuis
CollaboratorUNKNOWN
UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* buccal mucosal squamous cell carcinoma * surgical removal under general anesthesia

Exclusion criteria

* tumor is not visible on ultrasound as echolucent region

Design outcomes

Primary

MeasureTime frameDescription
Number of involved marginswithin 2 weeks after surgeryNumber of involved margins

Secondary

MeasureTime frameDescription
Sensitivity and specificity of ultrasound for identifying involved marginswithin 2 weeks after surgeryaccuracy of ultrasound
Number of patients with an indication for local adjuvant therapywithin one month after surgeryneed for local adjuvant treatment
Quality of life assessed by questionnaires at 4 timepointsbefore surgery, at 4, 8, and 12 months after surgeryInfluence of treatment on quality of life

Contacts

Primary ContactCarleen Adriaansens, MSc
c.m.e.m.adriaansens-2@umcutrecht.nl088-7567805
Backup ContactRob Noorlag
r.noorlag-3@umcutrecht.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026