NCT04519554

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Biopsy

Interventions

Type	Name	Description
DEVICE	Endometrial sampling	Endometrial sampling with 2 different forceps

Timeline

• Start date: 2020-09-20
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2020-08-19
• Last updated: 2020-09-01

Locations

1 site across 1 country: France