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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Biopsy

Treatments: Device: Endometrial sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04519554

APHP200243

2017-A00621-52 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 146 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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146 participants in 2 patient groups

5FR + 7FR

Other group

Description:

Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR

Treatment:

Device: Endometrial sampling

7FR + 5FR

Other group

Description:

Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR

Treatment:

Device: Endometrial sampling