Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Tissue yield
研究概览
简要总结
In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.
This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.
详细描述
Ovarian cancer is known to be the 4th most lethal tumour in women and has the highest mortality rate of all gynaecological malignancies. In most women, the disease is not diagnosed until advanced stage [1]. Moreover, the pelvis and ovaries in particular, are also a common place for secondary metastases. In 4% of ovarian masses, metastasis can be found from a tumour with another primary origin [2]. In primary ovarian cancer, patients may benefit from either primary debulking surgery or neoadjuvant therapy, depending on tumour staging and patients' comorbidities [5]. In recurrent disease treatment may include surgery, radiotherapy or systemic therapy, depending on primary tumour histology, extent of recurrence, previous treatment and disease-free interval [6-8]. In pelvic masses with ultrasound features suggesting metastatic disease, management will be guided by the origin of the primary tumour [9,10]. Therefore, histological diagnosis is important to select the optimal treatment strategy.
Tissue sampling by diagnostic laparoscopy or explorative laparotomy requires general anaesthesia and hospital admission, leading to higher costs and to potential surgical morbidity. Moreover, diagnostic laparoscopy is associated with a risk of port-site metastasis, ranging from 0.3-0.4% in endometrial and cervical cancer [11] and even 17-49% in advanced ovarian cancer [12,13].
Minimally invasive procedures for diagnosis include fine-needle aspiration and tru-cut biopsy.
At fine-needle aspiration the quantity and integrity of the tissue is limited, enabling cytological evaluation only [14]. Tru-cut biopsy results in a higher specificity compared to fine needle biopsy and it enables histological examination including immunohistochemistry [15,16].
A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). However, percutaneous CT-guided biopsies of deep pelvic masses are challenging because vital structures often obstruct the needle pathway [17].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Following lesion criteria applicable for biopsy:
- •Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)
- •Solid component present (purely cystic lesions excluded)
- •Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.
- •In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:
- •Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and
- •Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing
- •Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and/or diagnostic laparoscopy
- •Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
- •Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.
- •Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
- •Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.
排除标准
- •Patients < 18 years
- •Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.
- •Vaginal or pelvic infection
- •Poor performance status contraindicating any specific oncologic treatment
结局指标
主要结局
Tissue yield
时间窗: 6 weeks after procedure
Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.
Safety
时间窗: 6 weeks
Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.
次要结局
- Patient experience(3 days)
- Factor 4 affecting safety and tissue yield(6 weeks)
- Patient pain score(3 days)
- Factor 2 affecting safety and tissue yield(6 weeks)
- Factor 1 affecting safety and tissue yield(6 weeks)
- Factor 3 affecting safety and tissue yield(6 weeks)
- Factor 5 affecting safety and tissue yield(6 weeks)
- Histological diagnosis(6 weeks)