Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of cases of recurrent high-grade cervical intraepithelial neoplasia
研究概览
简要总结
This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
详细描述
Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 21-45 years old
- •Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
- •Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
- •Satisfactory (adequate) colposcopy.
- •Lives within 100 miles of the University of Alabama at Birmingham.
排除标准
- •Any suspicion for invasive cancer.
- •Glandular abnormalities on cytology or histology.
- •Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
- •Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
- •Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives >100 miles away will be excluded due to concern for possible loss to follow-up.
- •Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.).
- •Pregnancy.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
结局指标
主要结局
Number of cases of recurrent high-grade cervical intraepithelial neoplasia
时间窗: 6 months
Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
次要结局
- Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia(Within 1 week following focal LEEP procedure)
- Acceptability of focal LEEP procedure(2 weeks following focal LEEP procedure)
研究者
Michelle Khan
Assistant Professor
University of Alabama at Birmingham