5- Fluorouracil as a novel adjunctive therapy for conservative management of Ameloblastoma – a randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2) Radiographic Healing of lesion
研究概览
简要总结
Ameloblastoma is a benign aggressive lesion which has been known to expand beyond its margins and cause bone perforation and affect adjacent structures as well causing facial swelling.
Various treatment modalities have been suggested to manage such a conditionm including currettage, decompression and enucleation with adjuvant therapies like carnoy’s solution, cryotherapy and electrocautery.
All of these treatment modalities couldn’t limit the recurrecne of these lesions. Resection is the only modality which offers least amount of recurrence but it causes facial disfigurement which requires reconstruction which again is an expensive procedure.
Recent studies suggested the connection between sonic hegdehog pathway and ameloblastoma and downregulating effect of 5-FU on the sonic hegdehog pathway.
5-FU is a chemotherapeutic drug and has found to have been effective in the management of Ameloblastic carcinoma and Malignant Ameloblastona.
There is a scarcity of literature discussing the rationality of using 5-FU in the conservative management of Ameloblastomna.
Furtehr studies are required to study the effects of 5-FU in the conservative management of Ameloblastoma of the jaws and the protocol to use 5-FU in the management of Ameloblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •All the Histopathologically diagnosed cases of Ameloblastoma reporting in OPD.
- •All patients willing and fit for surgery.
- •All the cases who are undergoing treatment for the 1st time.
排除标准
- •Patients with diagnosis other than Ameloblastoma reporting in OPD 2) Patients unwilling and unfit for surgery.
- •Patients who are lost to follow up.
- •Recurrent cases or Aggressive Case of Ameloblastoma.
结局指标
主要结局
2) Radiographic Healing of lesion
时间窗: 1) Nerve Paresthesia - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 2) Radiographic Healing of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 3) Recurrence of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years
1) Nerve Paresthesia
时间窗: 1) Nerve Paresthesia - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 2) Radiographic Healing of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 3) Recurrence of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years
3) Recurrence of lesion
时间窗: 1) Nerve Paresthesia - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 2) Radiographic Healing of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years. | 3) Recurrence of lesion - pre-op, post-op, 1 month, 3 months, 6 months, 1 year, 1 year 6 months, 2 years
次要结局
- Volumetric Analysis of the cavity following excision.(Pre-op - S0)
