Buccal Cancer Resection Ultrasound Guided

NCT ID: NCT05852665

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-03-01

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.

Conditions

Buccal Mucosa Cancer; Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound-guided surgery

Group Type: EXPERIMENTAL

Ultrasound-guided resection

Intervention Type: DEVICE

Ultrasound-guided resection of buccal squamous cell carcinomas

Interventions

Ultrasound-guided resection

Ultrasound-guided resection of buccal squamous cell carcinomas

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• tumor is not visible on ultrasound as echolucent region

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role: collaborator

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Antoni van Leeuwenhoek Ziekenhuis

UNKNOWN

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Rob Noorlag

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Carleen Adriaansens, MSc

Role: CONTACT

c.m.e.m.adriaansens-2@umcutrecht.nl

088-7567805

Rob Noorlag

Role: CONTACT

r.noorlag-3@umcutrecht.nl

Other Identifiers

NL83714.041.23

Identifier Type: -

Identifier Source: org_study_id