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

NCT ID: NCT06845982

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-10-01

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.

Conditions

Uterine Fibroids (UF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ultrasound-guided transuterine vaginal biopsy (BVTE)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Conception

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laura Miquel Dr

Role: CONTACT

promotion.interne@ap-hm.fr

+33491381927

Facility Contacts

Laura Miquel Dr

Role: primary

promotion.interne@ap-hm.fr

+33491381927

Other Identifiers

2024-A01337-40

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM23_0387

Identifier Type: -

Identifier Source: org_study_id