Biopsy
Conditions
Keywords
endometrial sampling hysteroscopy, postmenopausal bleeding, endometrial carcinoma
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
Interventions
DEVICEEndometrial sampling
Endometrial sampling with 2 different forceps
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies | During the pathologist's analysis | Evaluated by the number of cases on witch the biopsy allowed to conclude |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare histologic conclusions after 5 and 7Fr biopsies | During the pathologist's analysis | Evaluated by Importance of collapse artifacts |
| To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma | During the pathologist's analysis | The number of endometrial malignancies diagnosed histologically with either forceps |
| To evaluate the rate of hysteroscopic failure due to cervical stenosis | During the pathologist's analysis | The number of cases where hysteroscopy was not possible |
Countries
France
Contacts
Primary ContactPerinne CAPMAS
Outcome results
None listed