NCT06845982

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids (UF)

Interventions

Type	Name	Description
OTHER	ultrasound-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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-03-01
• Completion: 2028-10-01
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: France