Actively Recruiting
Pipelle4 Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding: Randomised Controlled Trial
Led by Imperial College Healthcare NHS Trust · Updated on 2024-07-15
92
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a method to improve tissue sampling for women experiencing vaginal bleeding after menopause, which may indicate endometrial cancer. The study compares the traditional blind Pipelle4 endometrial biopsy with a new approach using transabdominal ultrasound guidance to increase the chances of obtaining an adequate sample. This randomized controlled trial aims to see if ultrasound guidance reduces the need for more invasive tests, lessens pain, improves patient satisfaction, and shortens time to treatment. The trial includes two groups: one receiving the standard blind biopsy and the other undergoing the biopsy with ultrasound guidance using a probe on the lower abdomen. Both procedures use the Pipelle4 device, with 46 patients in each group. The ultrasound-guided group has an additional transabdominal scan during sampling to help the doctor navigate the biopsy device to the correct location. The study is conducted in an outpatient gynecological oncology department and will last for three years. Participants will have demographic and medical data collected, including ultrasound findings and biopsy results. Pain, anxiety, and satisfaction are measured using a Visual Analogue Scale questionnaire immediately after the procedure. Histopathology results will be reviewed to confirm sample adequacy and diagnose conditions such as benign pathology, hyperplasia, or cancer. Follow-up aligns with standard care: patients with benign results are discharged, while those with abnormal findings receive further management. Safety and complications are monitored throughout the study.
CONDITIONS
Brief Title
Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with post-menopausal bleeding who need 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
- Endometrium thickness of 5mm or more on ultrasound
- Smooth, uniform endometrium with a clearly defined border
You will not qualify if you...
- Presence of focal endometrial pathology such as polyps, fibroids, uterine septa, or other uterine abnormalities
- Suspicion of non-benign myometrial disease
- History of endometrial cancer or endometrial hyperplasia
- History of cervical cancer
- Virginity (virgo intacta)
- Unable to tolerate vaginal examination
- Unable or unwilling to give informed consent
- Withdrawal or denial of written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure visit
Participants undergo a Pipelle® endometrial biopsy to obtain a tissue sample for histopathological assessment. This biopsy is performed either under transabdominal ultrasound guidance or without ultrasound guidance depending on the assigned study arm.
1 visit (in-person)
Duration - Up to 2 weeks after biopsy
Participants receive follow-up care based on biopsy results. Those with benign results are discharged with a letter sent to their GP, while participants with non-benign pathology may have further appointments and follow-up as per clinical protocols. Participants with inadequate samples may be contacted for additional assessment such as hysteroscopy.
1 follow-up visit if non-benign pathology is found or sample is inadequate
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
N
Nicholas PC Anson, MBBS
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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