Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576362
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFIBIA
Brief Summary:
The goal of this diagnostic prospective study is to evaluate an innovative minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy in women aged 18 and more and to evaluate complications relating to the the technique and its potential adverse events
Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study
Preoperatively women will undergo the following two examinations
1 A pelvic MRI the characteristics of which will be analyzed by the expert women39s imaging team
2 A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy
250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months
Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study
Preoperatively women will undergo the following two examinations
1 A pelvic MRI the characteristics of which will be analyzed by the expert women39s imaging team
2 A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy
250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months
Detailed Description:
Fibroma is the most common uterine smooth muscle tumor Women are symptomatic in 30 of cases A large proportion of fibroids are asymptomatic and discovered on imaging Surgical management is the only recommended first-line treatment option in cases of symptoms Hysterectomy is the most radical treatment but for women wishing to preserve their fertility myomectomy is the most suitable option This is performed by hysteroscopy laparoscopy or laparotomy The main risk of myomectomy is massive intraoperative haemorrhage requiring blood transfusion or even a haemostasis hysterectomy There are non-surgical alternatives using embolization and radiofrequency but these techniques do not provide a definitive diagnosis of fibroids as they do not involve histological sampling
The benign uterine fibroma is part of the broader concept of uterine smooth muscle tumors which also includes myometrial malignancies of varying malignancy uterine sarcomas cellular fibromas STUMP Uterine smooth muscle tumors of uncertain malignant potential
Magnetic resonance imaging MRI is the most effective examination for discriminating fibroids from TMM but its reliability is limited This leads to inappropriate management in a number of situations The first is the risk of over-treatment by performing surgery for 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 even deleterious carcinological surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM The last situation is the possibility of treating a lesion labelled fibroid on MRI with an alternative technique embolization radiofrequency HIFU when it is in fact a TMM thereby delaying appropriate management and worsening the prognosis
Ultrasound-guided transuterine vaginal biopsy ETVB is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis It can be used to obtain a histological diagnosis thus avoiding the need for surgery and the inappropriate treatment described above Primary objective To validate an innovative minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
Secondary objectives Evaluate the complications associated with the technique as well as its potential adverse effects
Exploratory objectives To assess the feasibility of the technique in routine practice
Primary endpoint Estimation of the anatomopathological sensitivity of BVTE with its 95 confidence interval by comparing it with the reference technique ie anatomopathological diagnosis on surgical specimen to ensure a low number of false negatives fibroid diagnosis on BVTE with final diagnosis of TMM
Secondary endpoints Estimation of specificity positive and negative predictive values and likelihood ratios of BVTE with their confidence intervals number of intraoperative and postoperative complications according to the Clavien-Dindo classification
Exploratory criteria if applicable Evaluation of equipment availability cost simplicity of performance as assessed by the operator
The benign uterine fibroma is part of the broader concept of uterine smooth muscle tumors which also includes myometrial malignancies of varying malignancy uterine sarcomas cellular fibromas STUMP Uterine smooth muscle tumors of uncertain malignant potential
Magnetic resonance imaging MRI is the most effective examination for discriminating fibroids from TMM but its reliability is limited This leads to inappropriate management in a number of situations The first is the risk of over-treatment by performing surgery for 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 even deleterious carcinological surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM The last situation is the possibility of treating a lesion labelled fibroid on MRI with an alternative technique embolization radiofrequency HIFU when it is in fact a TMM thereby delaying appropriate management and worsening the prognosis
Ultrasound-guided transuterine vaginal biopsy ETVB is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis It can be used to obtain a histological diagnosis thus avoiding the need for surgery and the inappropriate treatment described above Primary objective To validate an innovative minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy
Secondary objectives Evaluate the complications associated with the technique as well as its potential adverse effects
Exploratory objectives To assess the feasibility of the technique in routine practice
Primary endpoint Estimation of the anatomopathological sensitivity of BVTE with its 95 confidence interval by comparing it with the reference technique ie anatomopathological diagnosis on surgical specimen to ensure a low number of false negatives fibroid diagnosis on BVTE with final diagnosis of TMM
Secondary endpoints Estimation of specificity positive and negative predictive values and likelihood ratios of BVTE with their confidence intervals number of intraoperative and postoperative complications according to the Clavien-Dindo classification
Exploratory criteria if applicable Evaluation of equipment availability cost simplicity of performance as assessed by the operator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None