Buccal Cancer Resection Ultrasound Guided

Not Applicable

Not yet recruiting

• Conditions: Buccal Mucosa Cancer; Squamous Cell Carcinoma
• Interventions: Device: Ultrasound-guided resection

• Registration Number: NCT05852665
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-01
• Last Update Submitted: 2023-05-01
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Study Start: 2023-09-01
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• tumor is not visible on ultrasound as echolucent region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided surgery	Ultrasound-guided resection	-

Primary Outcome Measures

Name	Time	Method
Number of involved margins	within 2 weeks after surgery	Number of involved margins

Secondary Outcome Measures

Name	Time	Method
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
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