跳至主要内容
临床试验/CTRI/2024/03/064106
CTRI/2024/03/064106尚未招募4 期

5- Fluorouracil as a novel adjunctive therapy for conservative management of Ameloblastoma – a randomized control trial

Dr Priyanka Shetty1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月4日最近更新:

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)

研究者

发起方
Dr Priyanka Shetty
申办方类型
Other [Individual Sponser]

研究点 (1)

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