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

Biopsy Clinical Trial

— HYSTEROBIO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04519554
• Other study ID #: APHP200243
• Secondary ID: 2017-A00621-52
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Perinne CAPMAS
• Phone: +33(0)145217701
• Email: perinne.capmas[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biopsy

Intervention

Device:
• Endometrial sampling
Endometrial sampling with 2 different forceps

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare histologic conclusions after 5 and 7Fr biopsies	Evaluated by Importance of collapse artifacts	During the pathologist's analysis
Secondary	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
Secondary	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