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.
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
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
* Age ≥ 18 years * Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s))
Cohort
Prospective
tru cut biopsy
Procedure/SurgeryProving that preoperative TCB could provide accurate information about the histological nature of the tumor would have great impact for setting an adequate, tailored, oncologically safe treatment approach.
Rate of accuracy
Accuracy is defined as the concordance of the results of preoperative histology from TCB with the result of definitive histology from the operative specimen
Rate of adequately performed TCBs
defined as the number of TCBs with adequate encroachment of the lesion with bioptic needle (by the US) and sufficient tissue sample for the histopathological analysis to the total number of TCBs.
Number of complications
number of complications after TCB divided by the number of patients. Intraoperative and early post-procedural complications will be assessed using a questionnaire. Adverse events will be assessed 14th post-TCB day according to the Clavien-Dindo Surgical complications classification
Pain associated with TCB
Assessment of patient´s pain during, 30 minutes after, and 24 hours after the procedure using the Numeric rating scale (NRS)
Comparison of the preoperative MRI examination to US imaging
Testing the superiority of either approach, sensitivity and specificity of the MRI imaging when compared to US examination will be analyzed
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