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

Not Applicable

• Conditions: Biopsy
• Interventions: Device: Endometrial sampling

• Registration Number: NCT04519554
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01
• Study Start: 2020-09-20
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
To compare histologic conclusions after 5 and 7Fr biopsies	During the pathologist's analysis	Evaluated by Importance of collapse artifacts

Trial Locations

Locations (1)

AP-HP, Bicêtre Hospital; 🇫🇷 Le Kremlin Bicêtre, France