Safety and Clinical Outcomes of Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Recurrence
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:
• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?
Participants will:
- Receive the first session CDS for endometrioma
- Carry the catheter overnight and be monitored in the patient ward
- Receive the second session CDS the next day
详细描述
Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years
- •Symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain)
- •Endometrioma ≥ 3 cm confirmed on ultrasound
- •No evidence of solid lesions on ultrasound
- •No suspected extraovarian endometriosis
排除标准
- •History of gynecologic malignancy
- •Active inflammation or infection
- •Abnormal coagulation profile
- •Loss to follow-up
研究组 & 干预措施
Two-session catheter-directed sclerotherapy
Each patient received two sessions of catheter-directed sclerotherapy for endometrioma 1 day apart with the catheter left in situ overnight.
干预措施: Two-session catheter-directed sclerotherapy (Procedure)
结局指标
主要结局
Recurrence
时间窗: Recurrence was assessed at 1, 3, and 6 months after the procedure.
Recurrence of endometrioma was assessed
次要结局
未报告次要终点
研究者
Ji Hoon Shin
Professor
Asan Medical Center