MedTrace Logo

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

NCT06501846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance

The placement of an ultrasound probe on the lower abdomen while a Pipelle® endometrial biopsy is obtained.

PROCEDURE

Pipelle® endometrial biopsy performed without ultrasound guidance

A Pipelle® endometrial biopsy is performed by using touch alone.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Joseph Yazbek, MD · Imperial College Healthcare Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2027-07-23
Completion
2027-07-23

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501846 on ClinicalTrials.gov