Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)

Study Overview
=================
Brief Summary
-----------------
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.

Detailed Description
-----------------
Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies. A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies

Official Title
-----------------
Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)

Conditions
-----------------
Biopsy

Intervention / Treatment
-----------------
* Device: Endometrial sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old. Woman who speak and understand french Woman who give her written informed consent Woman covered by french medical insurance Exclusion Criteria: • Pregnant or breastfeeding patient Patient under guardianship, curators or safeguard of justice. Patient participating in another ongoing study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 5FR + 7FR<br>Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR | Device: Endometrial sampling<br>* Endometrial sampling with 2 different forceps<br>|
| Other: 7FR + 5FR<br>Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR | Device: Endometrial sampling<br>* Endometrial sampling with 2 different forceps<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies | Evaluated by the number of cases on witch the biopsy allowed to conclude | During the pathologist's analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare histologic conclusions after 5 and 7Fr biopsies | Evaluated by Importance of collapse artifacts | During the pathologist's analysis | 
| To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma | The number of endometrial malignancies diagnosed histologically with either forceps | During the pathologist's analysis | 
| To evaluate the rate of hysteroscopic failure due to cervical stenosis | The number of cases where hysteroscopy was not possible | During the pathologist's analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial sampling hysteroscopy, postmenopausal bleeding, endometrial carcinoma