Pipelle® under Ultrasound Guidance
Research type
Research Study
Full title
Pipelle® under Ultrasound Guidance (PUG) to investigate post-menopausal bleeding: Randomised Controlled Trial
IRAS ID
335483
Contact name
Joseph Yazbek
Contact email
Sponsor organisation
Imperial College Healthcare Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This trial aims to investigate whether, in post-menopausal women, outpatient endometrial biopsies can be better obtained by performing this procedure under ultrasound guidance when compared with the traditional 'blind' approach.
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.
The two methods of doing this are (i) by using a small plastic tube biopsy device (such as a Pipelle®) in the outpatient setting, this is referred to as an outpatient endometrial biopsy, or (ii) performing a minor surgical procedure called a hysteroscopy. Outpatient endometrial biopsy is a quicker, less invasive and cheaper option that is appropriate as a first line investigation in most women. However, a significant number of attempted Pipelle® biopsies are unsuccessful in obtaining a sample that is adequate for histopathological assessment.
This trial will use an ultrasound probe placed on the lower stomach (transabdominal ultrasound) to try and guide the doctor performing the outpatient endometrial biopsy. The aim is to establish whether if by doing this there is an improvement in the rate of obtaining an adequate sample. 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 or advice after their biopsy is reduced.
The trial will be performed in the outpatient gynaecological oncology department at Queen Charlotte's and Chelsea Hospital, part of Imperial College Healthcare Trust. The trial will run for three years with 92 patients participating. It will be a randomised controlled trial. This study has not sought any funding.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0244
Date of REC Opinion
23 May 2024
REC opinion
Further Information Favourable Opinion