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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroids (UF)
• Intervention / Treatment: Other: ultrasound-guided transuterine vaginal biopsy (BVTE)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Miquel Dr; Phone Number: +33491381927; Email: promotion.interne@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Hopital Conception
    • Contact: Laura Miquel Dr; Phone Number: +33491381927; Email: promotion.interne@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomopathological analysis of biopsy with BVTE technique and comparison with the reference technique	The main aim of our study will be to evaluate the diagnostic performance of a BVTE biopsy technique for preoperative uterine smooth muscle tumours to discriminate between fibroids and MCTs.	Form enrollement to the end of the study at 43 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intraoperative complications according to the Clavien-Dindo classification	The secondary objective of this study will be to count the numbre of intraoperatoire complications associated with the BVTE technique, in comparison with the reference technique.	During the surgery
Number of postoperative complications according to the Clavien-Dindo classification	The secondary objective of this study will be to count the numbre of postoperatoire complications associated with the BVTE technique, in comparison with the reference technique.	From the surgery to the end of the study at 43 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of equipment in accordance with number of patients in current practice	The exploratory objectives will be to assess the feasibility of the technique in current practice. So investigators will evaluate the number of equipment available for the technique in current practice in comparison with a reference technique.	From enrollement to the end of the study at 43 months
Cost (euros) of the BVTE technique in current practice	The exploratory objectives will be to assess the feasibility of the technique in current practice. So investigators will evaluate the cost of the technique in current practice in comparison with a reference technique.	From enrollement to the end of the study at 43 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: RCAPHM23_0387; 2024-A01337-40 (Other Identifier: RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No