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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00621-52 | Other Identifier | IDRCB |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5FR + 7FR | Other | Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR |
|
| 7FR + 5FR | Other | Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial sampling | Device | Endometrial sampling with 2 different forceps |
|
| 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 |
| 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 |
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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.
Exclusion Criteria:
• Pregnant or breastfeeding patient
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perinne CAPMAS | Contact | +33(0)145217701 | perinne.capmas@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Perine CAPMAS | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital | Le Kremlin-Bicêtre | 94275 | France |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |