Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorImperial College Healthcare NHS Trust
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
All patients with post-menopausal bleeding who require an endometrial biopsy.
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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance
Procedure/SurgeryThe placement of an ultrasound probe on the lower abdomen while a Pipelle® endometrial biopsy is obtained.
Pipelle® endometrial biopsy performed without ultrasound guidance
Procedure/SurgeryA Pipelle® endometrial biopsy is performed by using touch alone.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Blind Endometrial BiopsyPlacebo comparator 1 intervention
Group B: Ultrasound Guided Endometrial BiopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adequate endometrial biopsy (Yes/No).
Sufficient intact endometrial tissue to safely diagnose or exclude endometrial cancer and endometrial hyperplasia, as assessed by a histopathologist.
Time frame
3 yearsSecondary outcomes
1
Patient satisfaction (Visual Analogue Scale, 0-10).
Questionnaire with four questions: 1. What was your level of anxiety leading up to your appointment today? (Visual Analogue Scale showing all numbers 0 - 10, 0 lowest anxiety - 10 highest anxiety) 2. What was your pain level during your biopsy today? (Visual Analogue Scale showing all numbers 0 - 10, 0 lowest pain - 10 highest pain) 3. What was your pain level after your biopsy today? (Visual Analogue Scale showing all numbers 0 - 10, 0 lowest pain - 10 highest pain) 4. How satisfied are you with your experience in the clinic today? (Visual Analogue Scale showing all numbers 0 - 10, 0 lowest satisfaction - 10 highest satisfaction)
Time frame
3 years2
Time to treatment (Days). To determine whether women undergoing an outpatient Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance have a shorter time from their biopsy to receiving definitive treatment.
Days from the initial Pipelle® endometrial biopsy attempt until treatment in cases of endometrial cancer or endometrial hyperplasia.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov