RecruitingNot ApplicableNCT06845982

Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease


Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

250 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The benign uterine fibroid is part of the broader term uterine smooth muscle tumour, which also includes malignant myometrial tumours (MSTs) of varying malignancy (uterine sarcoma, cellular fibroid, STUMP (uterine smooth muscle tumours of uncertain malignant potential)). Magnetic resonance imaging (MRI) is the most effective test for distinguishing a fibroid from a TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of overtreatment by performing surgery for a suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory or even harmful cancer surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. Finally, there is the possibility of treating a lesion labelled as a fibroid on MRI with an alternative technique (embolisation, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate treatment and worsening the prognosis. Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It would make it possible to obtain a histological diagnosis without the need for surgery, thereby avoiding the inappropriate management described above. The aim of this study is to validate an innovative minimally invasive surgical technique (BVTE) for the diagnosis of uterine smooth muscle tumours by biopsy, to assess the complications associated with the technique and any potential adverse effects, and to evaluate the feasibility of the technique in current practice.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new ultrasound-guided biopsy technique that accesses uterine fibroids (benign muscle tumors of the uterus) through the vagina, to see whether the tissue samples obtained are accurate enough to distinguish fibroids from a rarer, more serious type of uterine muscle tumor. **You may be eligible if...** - You are over 18 years old - You are being seen at CHU de la Conception hospital in France - You require surgical treatment for uterine smooth muscle tumors (fibroids or other uterine muscle tumors) - You are covered by or eligible for the French social security system **You may NOT be eligible if...** - You are currently enrolled in another research study - You are pregnant, in labor, or breastfeeding - You are a minor, detained, or under legal guardianship - You are unable to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERultrasound-guided transuterine vaginal biopsy (BVTE)

A BVTE is performed under general anaesthetic in the operating theatre on the scheduled day of myomectomy or hysterectomy. It will be directed to the centre of the uterine smooth muscle tumour in question via an exclusively transuterine route to avoid any peritoneal spread. At least 4 to 5 samples will be taken per uterine smooth muscle tumour, with a maximum of 3 tumours to limit the risk of confusion. The woman will then be operated on as planned during the same operation. All surgical specimens will be sent to the Anatomopathology Department of La Timone for anatomopathological diagnosis after immediate formalin embedding during surgery. Surgical specimens will be analysed as usual.


Locations(1)

Hopital Conception

Marseille, France

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NCT06845982


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