A study on the utility of preoperative ultrasound to locate the lateral most extent of buccal cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Primary objective is to estimate the rate of inadequate less than or equal to 1 mm lateral margin LM with respect to other anterior
研究概览
简要总结
Buccal cancers have a higher risk of inadequate surgical margins especially at the lateral margin which strongly predicts local recurrence This occurs due to the difficulty in assessing tumor extent and surgeons tendency to preserve uninvolved cheek skin Although CT MRI and USG have been used to plan skin resection their effect on the histopathologic adequacy of the LM is unclear This prospective study evaluated whether preoperative USG could accurately map the lateral most tumor extent guide surgeons to high risk areas and reduce the rate of inadequate less than or equal to 1 mm lateral margins Patients with buccal squamous cell carcinoma undergoing primary surgery at KMCH were included those with prior treatment neoadjuvant chemotherapy, prior surgery for the index cancer prior head and neck irradiation primary tumor of the alveolus non squamous cancers lip and commissure primaries or skin involvement were excluded Each patient underwent preoperative USG mapping by a head and neck radiologist The most lateral location of the tumor assessed and the corresponding area marked on the skin with plaster and the circumferential border of the plaster would be marked on the skin by methylene blue tattoo and the plaster removed before surgery Surgeons aimed for greater than or equal to 10 mm gross margins paying special attention to the marked lateral area and extending resection including skin if needed After resection specimens were oriented and labeled and margins were measured in five planes anterior posterior superior inferior and lateral deep plane nearest the skin Chi square test used to examine the categorical data to estimate the rate of inadequate lateral margin less than or equal to 1 mm compared with the other surgical margins anterior posterior superior and inferior and to compare the rate of inadequate margin less than or equal to 1 mm within the marked lateral resection area target LM with respect to the rest of the area on the lateral resection plane outside target lateral margin
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged more than 18 years old undergoing primary surgical treatment for biopsy proven buccal mucosal cancer of squamous cell type staged I to IV.
排除标准
- •Carcinoma other than squamous cell carcinoma Patient who received neoadjuvant chemotherapy Patient with prior surgery for the index cancer Patient with prior head and neck irradiation Patient with primary tumor of the lip or commissure Patient with primary tumor of the alveolus with nil or minimal involvement of the adjacent buccal mucosa Patient with tumor proximity less than 10 mm gross distance to the oral commissure Patient with clinical involvement of skin or subcutaneous tissue tumor penetration or fungating through skin skin fixity by tumor lack of skin mobility or presence of edema peau d orange or discoloration over the tumor area.
结局指标
主要结局
Primary objective is to estimate the rate of inadequate less than or equal to 1 mm lateral margin LM with respect to other anterior
时间窗: It is a single point data collection study where the histopathological details are recorded and analysed during the study period
posterior superior and inferior margins in patients resected for buccal mucosal cancers as per inclusion criteria
时间窗: It is a single point data collection study where the histopathological details are recorded and analysed during the study period
次要结局
- The rate of skin resection during the surgical procedure
研究者
Dr Gayathri E
Kovai Medical Centre and Hospital