Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy' (HYSTEB)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Atrophic or Hypotrophic Endometrium

Study type: Observational

Funder types: Other

Identifiers

NCT07675317

HYSTEB

Details and patient eligibility

About

Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the "chip biopsy" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the "rail biopsy" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.

This observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of "chip biopsy" versus "rail biopsy" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.

Enrollment: 156 estimated patients

Sex: Female

Ages: 48 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 48 years and ≤ 75 years
• Women with atrophic endometrium, candidates for endometrial biopsy
• Informed consent obtained for participation in the study and for the processing of personal data

Exclusion criteria

• Presence of intrauterine fibroids, polyps, and adhesions;
• Current or recent (< 3 months) use of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
• Previous confirmed diagnosis of endometrial cancer;
• Suspected active pelvic inflammation or history of recent pelvic inflammation (< 6 months);
• Presence of severe stenosis or obliteration of the cervical canal.