Clinical trial NCT06845982: Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Official title: Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Fibroids (UF)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: Inclusion Criteria:

* Patients over 18 years of age consulting the CHU de la Conception who require surgical treatment for uterine smooth muscle tumours (fibroma or TMM).
* Able to give written consent
* Beneficiary or beneficiary of a social security scheme

Exclusion Criteria:

* Person in a period of exclusion from another research protocol at the time of signing consent/no objection
* Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
* Pregnant women, women in labour and nursing mothers
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8
* Minors
* Adults subject to a legal protection measure or unable to express their consent.
* A person who does not have a sufficient command of reading and understanding the French language to be able to consent to participate in the research.
* Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and/or interfere with the evaluation of the objectives of the research.

Primary outcomes:
measure: Anatomopathological analysis of biopsy with BVTE technique and comparison with the reference technique
timeFrame: Form enrollement to the end of the study at 43 months
Secondary outcomes:
measure: Number of intraoperative complications according to the Clavien-Dindo classification
timeFrame: During the surgery
measure: Number of postoperative complications according to the Clavien-Dindo classification
timeFrame: From the surgery to the end of the study at 43 months
Other outcomes:
measure: Number of equipment in accordance with number of patients in current practice
timeFrame: From enrollement to the end of the study at 43 months
measure: Cost (euros) of the BVTE technique in current practice
timeFrame: From enrollement to the end of the study at 43 months
Locations:
city: Marseille
country: France
facility: Hopital Conception
Study officials:
References: