Comparing Ex-Vivo Ultrasound aided and Frozen section analysis of deep margins with Final Histopathology in T1-T4 Carcinoma Tongue: A Prospective study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To determine accuracy of USG aided ex-vivo deep margin assessment with final histopathology.
研究概览
简要总结
The preferred modality of treatment for squamous cell carcinoma tongue is surgical resection. Free margin status >5mm is essential for local control and disease free survival. Submucosal or deep margins are often inadequate. Because patients with involved and close margins may require additional surges or adjuvant (chemo)radiotherapy, there is a need for technology that can provide real time, intraoperative feedback on margins. In this trial, we are going to determine the accuracy and consistency between ex vivo ultrasound aided and frozen section analysis of resected specimen to final histopathology in oral tongue squamous cell carcinoma.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 7.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient planned for surgery with biopsy proven Squamous Cell Carcinoma Lateral border of Tongue T1-T4 anyN M
- •2.Patient giving consent to participate in study.
排除标准
- •1.Patient who is not willing to participate in the study.
- •2.Patient is unfit for surgery under general anesthesia.
- •3.Patients of Carcinoma Tongue with metastasis M
- •4.Patients of Carcinoma Tongue any stage who have undergone Neoadjuvant Chemotherapy/Post op Chemotherapy and Radiotherapy.
结局指标
主要结局
1.To determine accuracy of USG aided ex-vivo deep margin assessment with final histopathology.
时间窗: 2 weeks
2.To determine accuracy of frozen section analysis for deep margin assessment with final histopathology.
时间窗: 2 weeks
次要结局
- To compare both techniques USG guided & Frozen section with respect to final histopathology(2 weeks)
研究者
Nivedhitha Murugesan
AIIMS NEW DELHI