Using ultrasound to guide endometrial biopsies for post-menopausal bleeding

Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding: Randomised Controlled Trial.

This study is testing if using ultrasound to guide endometrial biopsies can help women with post-menopausal bleeding get better tissue samples and avoid more invasive procedures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Imperial College Healthcare NHS Trust (other)
• Locations: 1 site (London)
• Trial ID: NCT06501846 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of using transabdominal ultrasound guidance during Pipelle® endometrial biopsies for women experiencing post-menopausal bleeding. The aim is to improve the success rate of obtaining adequate tissue samples for laboratory assessment, thereby reducing the need for more invasive procedures. Participants will be randomly assigned to receive either ultrasound-guided or standard biopsies. The study focuses on women with thickened endometrial linings who require biopsies to rule out endometrial cancer or hyperplasia.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who are experiencing post-menopausal bleeding and require an endometrial biopsy.

Not a fit: Patients with known focal endometrial pathology or a history of endometrial cancer or hyperplasia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and fewer invasive procedures for women with post-menopausal bleeding.

How similar studies have performed: Other studies have shown promise in using ultrasound guidance for biopsies, suggesting this approach may enhance diagnostic accuracy.

Eligibility criteria

Inclusion Criteria:

* All patients with post-menopausal bleeding who require an endometrial biopsy.

Further details:

* Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.
* There is no upper age limit, however all patients must be 18 or above.

Strict ultrasound criteria will be followed:

* Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.
* Smooth, homogenous endometrium with a clearly defined border.

Exclusion Criteria:

* Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).
* Suspicion of non-benign myometrial pathology.
* History of endometrial cancer or endometrial hyperplasia.
* History of cervical cancer.
* Virgo intacta.
* Inability to tolerate vaginal examination.
* Inability to consent.
* The denial or withdrawal of informed written consent.

Where this trial is running

London

• Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Joseph Yazbek, MD — Imperial College Healthcare Trust
• Study coordinator: Joseph Yazbek, MD

Conditions: Endometrial Cancer, Post-Menopausal Bleeding, Endometrial Hyperplasia, Pipelle Endometrial Biopsy, Ultrasound Guidance