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Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.

RecruitingNAAges 18 Years - anyFemaleImperial College Healthcare NHS Trust
NCT06501846 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

TITLE Pipelle® under Ultrasound Guidance (PUG) to investigate post-menopausal bleeding: Randomised Controlled Trial BACKGROUND Women who are suspected of having endometrial cancer (cancer of the inner lining of the womb) due to vaginal bleeding after the menopause must have a tissue sample taken from this area to determine whether there is an abnormality. One method of doing this is by using a small biopsy device (such as a Pipelle®) in the outpatient setting. This is referred to as an outpatient endometrial biopsy. However, a significant number of attempted endometrial biopsies are unsuccessful in obtaining a sample that is adequate for laboratory (histopathological) assessment. When an adequate sample is not obtained patients must then undergo more invasive testing. AIM This trial will use an ultrasound probe placed on the lower stomach (transabdominal ultrasound) to try and guide t

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance
  • Pipelle® endometrial biopsy performed without ultrasound guidance
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Where

1 site
Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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