Accuracy of Ultrasound Scan in Patients Undergoing Pelvic Exenteration and Laterally Extended Pelvic Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- pelvic exenteration resection.
研究概览
简要总结
Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.
详细描述
All consecutive patients who are planned to undergo pelvic exenteration or laterally extended pelvic resection at Policlinico Agostino Gemelli IRCCS, will undergo ultrasound scan at the time of the pre-operative anesthetic assessment or the day before the planned surgery. A pre-defined case report form (CRF) will be filled by the ultrasound examiner. The ultrasound characteristics will be compared with the final histology (considered the referral standard).
The ultrasound examinations will be carried out using high-end ultrasound equipment. The frequency of the vaginal probes varied between 5.0 and 9.0 MHz. All examinations will be performed by a specialist obstetrics and gynecology with expertise in gynecologic oncology ultrasound scan. A subjective semi-quantitative assessment of the amount of blood flow within the examined lesion will be made (color score): a score of 1 was recorded when no blood flow could be found; 2 when only minimal/moderate flow could be detected; 3 when very strong blood-flow signals were present.
All patients will undergo pre-operative MRI scan and PET/CT scan. Pelvic exenteration and laterally-extended pelvic resection will be performed with the aim to remove en bloc the recurrent or persistent disease with a free-of-tumor margin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent.
- •Anterior/total pelvic exenteration
- •Laterally extended endopelvic resection (LEER)
- •Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure
- •With or without stoma formation
排除标准
- •Radical hysterectomy without lateral resection
- •Rectal resection only (posterior exenteration)
结局指标
主要结局
pelvic exenteration resection.
时间窗: 30 minutes
The accuracy of US in the assessment of pelvic structures involvement in recurrent/persistent gynecologic tumors with disease limited to the pelvis.
次要结局
- accuracy of US with the accuracy of MRI(1 week)