RecruitingNAINTERVENTIONAL

Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.

This study, called PUG (Pipelle® Under Ultrasound Guidance), is for women experiencing bleeding after menopause. The main goal is to see if using a tummy ultrasound to guide a small device that takes a sample from the womb lining (called a Pipelle® biopsy) works better. Often, the usual method doesn't collect enough tissue, leading to more invasive tests. Researchers want to find out if this ultrasound guidance helps get enough samples, causes less pain for patients, and helps them get a diagnosis and treatment faster. It's a randomised study, meaning some women will have the biopsy with ultrasound guidance and others without, for comparison.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College Healthcare NHS Trust

Enrolment target

Start

23 Jul 2024

Estimated completion

23 Jul 2027

Endometrial Cancer Post-Menopausal Bleeding Endometrial Hyperplasia

What is this study about?

When women experience bleeding after they've gone through menopause, doctors often need to take a small sample from the lining of the womb to check for any changes. This is important because, in some cases, it can be a sign of something that needs treatment, like changes to the womb lining or even cancer, although thankfully most cases are not serious.

One common way to take this sample is called an 'endometrial biopsy' using a small device like a Pipelle®. It's usually done in an outpatient clinic, meaning you don't stay overnight in hospital. However, sometimes it's hard for the doctor to get a good enough sample for the laboratory to examine properly. When this happens, patients might need to have a more involved procedure which can be more uncomfortable.

This study aims to improve this process. Doctors will use a special ultrasound machine, placed on your tummy, to see exactly where they need to take the sample from. This guidance might help them get a better sample more often, potentially reducing the need for further, more invasive tests. The study also wants to see if this new approach causes less discomfort and helps women get their results and any necessary treatment more quickly.

Key takeaways

The study aims to improve womb lining biopsies for post-menopausal bleeding.
It tests using tummy ultrasound to guide the biopsy device (Pipelle®).
It hopes to get better samples, reduce pain, and speed up diagnosis.
Participation involves either an ultrasound-guided or standard biopsy.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is for women who have gone through menopause and are experiencing bleeding. Your doctor will have likely recommended that you need a biopsy of your womb lining because scans have shown that your womb lining is 5mm or thicker.

You would not be able to join if you have certain existing conditions related to your womb, like growths (polyps or some types of fibroids), or if you've already had womb or cervical cancer. Also, if you find it difficult to have a vaginal examination or cannot provide your permission to take part, this study would not be suitable.

There's no upper age limit, but you must be at least 18 years old. You need to have had no periods for at least a year, or for six months if you're on continuous hormone replacement therapy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman who has experienced bleeding after menopause?
Has your doctor recommended a womb lining biopsy for you?
Is your womb lining shown to be 5mm or thicker on an ultrasound scan?
Are you at least 18 years old?
Do you not have active womb or cervical cancer or large growths in your womb?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly placed into one of two groups. This means you will either have your womb lining biopsy with ultrasound guidance or without. The biopsy itself is similar to the standard procedure but with the added element of a tummy ultrasound for one group. The procedure takes place in the outpatient gynaecology department at Queen Charlotte's and Chelsea Hospital, part of Imperial College Healthcare NHS Trust.

Your participation will primarily involve this one biopsy appointment. Researchers will then look at whether a good sample was collected, how much discomfort you felt, and how quickly you received your final diagnosis and treatment. The study itself runs for a total of three years, but your direct involvement will be for a single visit and follow-up on your results.

Potential risks and benefits

Taking part in this study could potentially benefit you by providing a more successful biopsy, possibly reducing pain, and speeding up the time it takes to get a diagnosis and start any necessary treatment. However, as with any medical procedure, there are potential risks, though these are typically small with a Pipelle® biopsy. You might experience some discomfort or mild bleeding, and there's always a small chance that an adequate sample might not be obtained, meaning you'd need further tests. It's important to remember that you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is post-menopausal bleeding?

This is any bleeding you have after you have naturally stopped having periods for at least 12 months, or for 6 months if you are on continuous hormone replacement therapy.

What is a Pipelle® biopsy?

It's a quick procedure where a very thin tube is used to take a small sample of tissue from the lining of your womb for testing.

Will I know if I'm getting ultrasound guidance?

Yes, if you're in the group receiving ultrasound guidance, the doctor will use an ultrasound probe on your tummy during the procedure.

How long will my involvement in the study last?

Your direct involvement will mainly be for one appointment for the biopsy, with follow-up on your results.

Where is this study taking place?

It's being done at Queen Charlotte's and Chelsea Hospital, part of Imperial College Healthcare NHS Trust.

How to find out more

Joseph Yazbek, MD

joseph.yazbek@nhs.net 02033133570 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.