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临床试验/NCT07264660
NCT07264660尚未招募不适用

Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses

Assiut University0 个研究点目标入组 42 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy

研究概览

简要总结

Uterine tumor-like masses represent a wide spectrum of gynecological conditions, ranging from benign lesions such as myomas and adenomyosis to malignant tumors like endometrial carcinoma and leiomyosarcoma, as well as other entities including gestational trophoblastic disease [4]. Accurate preoperative diagnosis is crucial, since management varies from conservative follow-up to radical surgery or systemic therapy.

Imaging modalities such as ultrasound and MRI are essential in the initial evaluation of uterine masses, providing information on size, location, and internal characteristics. However, imaging alone often lacks specificity, as benign and malignant lesions may share overlapping features [4]. Thus, histopathological confirmation remains the gold standard.

Among available diagnostic approaches, transcervical ultrasound-guided true-cut biopsy offers unique advantages. Unlike dilatation and curettage, which may yield insufficient or fragmented tissue, this technique retrieves core samples with preserved architecture [1]. Compared to hysteroscopic biopsy, which mainly targets endometrial lesions and frequently requires anesthesia, the transcervical route can access intramural and submucosal lesions in a simple outpatient setting [2]. While Novak biopsy is suitable for outpatient endometrial sampling, it cannot adequately reach deeper myometrial or submucosal masses [4]. Furthermore, unlike the transabdominal approach, which may be limited by bowel interposition or patient habitus, the transcervical technique ensures direct, real-time ultrasound-guided targeting with high feasibility and accuracy [3].

Preliminary studies have demonstrated high sensitivity and specificity for transcervical true-cut biopsy [1-3,5]. However, prior research was often limited by small sample sizes, focus on specific pathologies rather than the full spectrum of uterine tumor-like masses, and lack of direct comparison with excisional biopsy as a gold standard. Therefore, this study will assess its diagnostic value in scheduled patients with uterine tumor-like masses, by evaluating the agreement between transcervical biopsy results and excisional biopsy. Ultimately, the aim is to determine whether this minimally invasive, outpatient technique can help avoid unnecessary surgeries in benign cases and ensure that patients with malignant disease proceed promptly to the most appropriate surgical intervention

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision.
  • Non-virgin patients .

排除标准

  • • Patients with active genital tract infection.
  • Patients with bleeding disorders or on uncorrected anticoagulation therapy.
  • .Pregnancy.

结局指标

主要结局

• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy

时间窗: 1 year

• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma AL_Zahraa Mohamed Mokhtar

Dr

Assiut University

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