Actively Recruiting
Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Led by Imperial College Healthcare NHS Trust · Updated on 2024-07-15
92
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with post-menopausal bleeding who require an endometrial biopsy
- Post-menopausal bleeding defined as bleeding one year after last menstrual period or six months after starting continuous combined hormone replacement therapy
- Age 18 years or older
- Endometrial thickness of 5 mm or more confirmed by ultrasound
- Smooth, homogenous endometrium with a clearly defined border
You will not qualify if you...
- Presence of focal endometrial pathology such as endometrial polyps, type 0-2 fibroids, uterine septa, or other structural abnormalities
- Suspicion of non-benign myometrial pathology
- History of endometrial cancer or endometrial hyperplasia
- History of cervical cancer
- Virgo intacta (never had vaginal intercourse)
- Inability to tolerate vaginal examination
- Inability or refusal to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
J
Joseph Yazbek, MD
CONTACT
N
Nicholas PC Anson, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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