Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding: Randomised Controlled Trial.
Imperial College Healthcare NHS Trust
92 participants
Jul 23, 2024
INTERVENTIONAL
Conditions
Summary
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 the doctor performing the endometrial biopsy with the aim of increasing the number of adequate samples that are obtained. The trial will also investigate if this technique is less painful and more acceptable to patients, and if the time taken for patients to receive definitive treatment after their biopsy is reduced. ELIGIBILITY All patients presenting with post-menopausal bleeding who have an endometrial thickness of 5mm or above without a contraindication to an outpatient endometrial biopsy. DESIGN Prospective randomised controlled trial enrolling 92 patients. When patients are entered into the study they will randomly assigned to one of two groups. One group will have their biopsy performed under transabdominal ultrasound guidance and the other will have the biopsy performed using the traditional 'blind' approach without ultrasound guidance. There will be 46 patients in each group. DURATION The trial will run for three years. The trial will be performed in the outpatient gynaecological oncology department at Queen Charlotte's and Chelsea Hospital, part of Imperial College Healthcare NHS Trust.
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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.
Interventions
The placement of an ultrasound probe on the lower abdomen while a Pipelle® endometrial biopsy is obtained.
A Pipelle® endometrial biopsy is performed by using touch alone.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06501846