Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
NCT Number: NCT06501846
Acronym: PUG
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Cancer|Post-Menopausal Bleeding|Endometrial Hyperplasia
Interventions: PROCEDURE: Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance|PROCEDURE: Pipelle® endometrial biopsy performed without ultrasound guidance
Sponsor: Imperial College Healthcare NHS Trust
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-23
Completion Date: 2027-07-23
Locations: Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust, London, W12 0HS, United Kingdom

Summary:
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.

Primary Outcome Measures: Adequate endometrial biopsy (Yes/No)., Sufficient intact endometrial tissue to safely diagnose or exclude endometrial cancer and endometrial hyperplasia, as assessed by a histopathologist., 3 years
Secondary Outcome Measures: 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), 3 years|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., 3 years