BRUG: Buccal Cancer Resection Ultrasound Guided
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ultrasound-guided surgery
|
Device: Ultrasound-guided resection
Ultrasound-guided resection of buccal squamous cell carcinomas
|
Outcome Measures
Primary Outcome Measures
- Number of involved margins [within 2 weeks after surgery]
Number of involved margins
Secondary Outcome Measures
- Sensitivity and specificity of ultrasound for identifying involved margins [within 2 weeks after surgery]
accuracy of ultrasound
- Number of patients with an indication for local adjuvant therapy [within one month after surgery]
need for local adjuvant treatment
- Quality of life assessed by questionnaires at 4 timepoints [before surgery, at 4, 8, and 12 months after surgery]
Influence of treatment on quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
-
buccal mucosal squamous cell carcinoma
-
surgical removal under general anesthesia
Exclusion Criteria:
- tumor is not visible on ultrasound as echolucent region
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- UMC Utrecht
- Rijnstate Hospital
- University Medical Center Groningen
- Medisch Spectrum Twente
- Medical Center Haaglanden
- Antoni van Leeuwenhoek Ziekenhuis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL83714.041.23