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

NCT06501846 | Recruiting

• 1 other identifier: 24QC8699
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Endometrial Cancer; Post-Menopausal Bleeding; Endometrial Hyperplasia

Keywords

Pipelle Endometrial Biopsy; Ultrasound Guidance

Outcome Measures

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.

  3 years

Secondary Outcomes (2)

• Patient satisfaction (Visual Analogue Scale, 0-10).

  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.

  3 years

Study Arms (2)

Blind Endometrial Biopsy

PLACEBO COMPARATOR

A Pipelle® endometrial biopsy performed in the routine manner without ultrasound guidance.

Procedure: Pipelle® endometrial biopsy performed without ultrasound guidance

Ultrasound Guided Endometrial Biopsy

EXPERIMENTAL

A Pipelle® endometrial biopsy performed with transabdominal ultrasound guidance.

Procedure: Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance

Interventions

Pipelle® endometrial biopsy performed under transabdominal ultrasound guidance PROCEDURE

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

Ultrasound Guided Endometrial Biopsy

Pipelle® endometrial biopsy performed without ultrasound guidance PROCEDURE

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

Blind Endometrial Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with post-menopausal bleeding who require an endometrial biopsy.
• Further details:
• 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.
• Strict ultrasound criteria will be followed:
• 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.
• Smooth, homogenous endometrium with a clearly defined border.

You may not qualify if:

• 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.
• Virgo intacta.
• Inability to tolerate vaginal examination.
• Inability to consent.
• The denial or withdrawal of informed written consent.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Joseph Yazbek, MD

  Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Yazbek, MD

CONTACT

02033133570; joseph.yazbek@nhs.net

Nicholas PC Anson, MBBS

CONTACT

nicholas.anson@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 15, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): July 23, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)