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

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.

Study Overview

• Status: Unknown
• Conditions: Biopsy
• Intervention / Treatment: Device: Endometrial sampling

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 Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perinne CAPMAS; Phone Number: +33(0)145217701; Email: perinne.capmas@aphp.fr

Study Locations

• France
  • Le Kremlin Bicêtre, France, 94275
    • AP-HP, Bicêtre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 5FR + 7FR; Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR	Device: Endometrial sampling; Endometrial sampling with 2 different forceps
Other: 7FR + 5FR; Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR	Device: Endometrial sampling; Endometrial sampling with 2 different forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Perine CAPMAS, APHP

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2020
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: postmenopausal bleeding; endometrial sampling hysteroscopy; endometrial carcinoma
• Other Study ID Numbers: APHP200243; 2017-A00621-52 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No