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

NCT04519554 | Unknown

• 2 other identifiers: APHP2002432017-A00621-52
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Biopsy

Keywords

endometrial sampling hysteroscopy; postmenopausal bleeding; endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To compare histologic conclusions after 5 and 7Fr biopsies

  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

  During the pathologist's analysis

• To evaluate the rate of hysteroscopic failure due to cervical stenosis

  During the pathologist's analysis

Study Arms (2)

5FR + 7FR

OTHER

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

7FR + 5FR

OTHER

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

Interventions

Endometrial sampling DEVICE

Endometrial sampling with 2 different forceps

5FR + 7FR; 7FR + 5FR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding patient
• Patient under guardianship, curators or safeguard of justice.
• Patient participating in another ongoing study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Perine CAPMAS

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perinne CAPMAS

CONTACT

+33(0)145217701; perinne.capmas@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: September 20, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)