The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions

The Tru-cut biopsy (TCB) for targeting pelvic tumors is well established in gynecologic oncology. However, its reliability for differentiating of uterine sarcoma in "myoma-like" uterine lesions has been confirmed by only a few studies, which were either retrospective or provided only pilot result on the limited number of prospectively enrolled patients (N=34). Proving that preoperative TCB can provide accurate information about the histological nature of the tumor would have great impact for setting an adequate tailored oncologically safe approach, especially in patients with sonographically atypical lesions. Additionally, the biopsy should be safe, with transcervical, transuterine cavity ("in organ" biopsy) approaches preferred to avoid the risk of needle canal contamination if sarcoma is diagnosed. The purpose of this study is to evaluate the accuracy of the Tru-cut biopsy (TCB) of sonographically atypical myometrial lesions as a complementary diagnostic method in the preoperative management of patients scheduled for uterus preserving procedure or hysterectomy. Additionally, we aim to assess the impact of this procedure on patients´ quality of life and clinical management. MYSTR is a single arm, prospective, multicentric cohort study.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s))
* USG finding of atypical myometrial lesion/s a

Exclusion Criteria:

patient 's refusal

* age \< 18 years
* ongoing pregnancy
* inability to perform TCB /contraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy)
* USG finding of more than 2 atypical lesion/s with a diameter ≤ 20 mm and ≥ 100 mm
* inability to perform any of the 3 core needle biopsy approaches (transvervical, trans uterine cavity, transvaginal) because of anatomical, localization issues. The percutaneous transabdominal biopsy is not allowed
* Polymyomatous uterus that may not be examined adequately with routine transvaginal ultrasound
* myoma (which would be subject to TCB) type 7 according to FIGO classification 16
* history of conservative hormonal therapy less than 3 months prior to study enrolment
* history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion
* history of pregnancy less than one year prior to study enrollment

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