Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?

Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy in the Detection of Endometrial Cancer?

Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).

All women presenting to clinic with suspected endometrial cancer will have an internal ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed. This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the clinician to perform directed biopsies under vision.

Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it is not routinely used in this context. It does have the advantage of being easily performed on the same day as the first consultation. In this pilot study we will assess the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer, as an alternative to hysteroscopy guided biopsy.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Hyperplasia; Endometrial Neoplasms; Endometrial Cancer; Endometrial Polyp
• Intervention / Treatment: Diagnostic test: Ultrasound guided biopsy

Detailed Description

Aims: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).

Background:

Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the UK. Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation - an endometrial biopsy (sampling cells from the womb lining) is indicated. The biopsy can be taken blindly or under scan or hysteroscopic guidance. Hysteroscopy, the insertion of a small camera into the womb to visualise the womb lining allows direct visualization of the cavity. This usually occurs at a separate consultation in an outpatient setting or under general anaesthesia.

In theory an ultrasound-guided biopsy using a very fine Bettocchi forceps could be used instead of hysteroscopy- guided biopsies of the endometrium. The technique of ultrasound-guided biopsy is ubiquitous when used elsewhere in the body. It is frequently used to provide histological diagnosis of pelvic masses, (presumed ovarian origin), both abdominally (scanning of the tummy) and transvaginally (internally). Potentially ultrasound guided biopsies could be used as a cheaper, faster and less painful alternative to a hysteroscopy directed biopsies. This pilot study will be the first to assess the diagnostic ability of ultrasound guided biopsy in the assessment of women with suspected endometrial cancer.

The study:

All women will receive a pelvic (internal) ultrasound as per routine care. If the endometrium (womb lining) is thickened >4mm on ultrasound they will require an endometrial biopsy. Usually this will be a pipelle. In cases where the pipelle biopsy cannot be performed in clinic due to poor tolerance, insufficient material or focal lesions a hysteroscopy guided biopsy will be required (local or GA).

In this case, the patients will be offered an ultrasound (USS) guided biopsy in the first instance, this will be performed at the same time in clinic. The biopsy will be taken under scan guidance using a very fine forceps such as Bettochi forceps. These forceps are used routinely during hysteroscopy so whilst the instruments are common the application is novel. The biopsy results of this will be sent for standard histology. If the results are inadequate patients will be sent for standard hysteroscopy and biopsy. Patients will also be asked to assess tolerability of the procedure using a visual analogue score.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Yazbek; Email: joseph.yazbek@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Queen Charlotte and Hammersmith Hospital
    • Principal Investigator: Jospeh Yazbek, FRCOG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

Exclusion criteria:

Anyone lacking capacity. <18years old. Pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Women needing endometrial biopsy; All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first.	Diagnostic test: Ultrasound guided biopsy; For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of histological diagnosis using ultrasound guided biopsy.	Accuracy of histological diagnosis using ultrasound guided biopsy.	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction of Ultrasound guided biopsy	Visual analogue score will be given to patients post procedure to assess tolerability of the procedure	1.5 years

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Biopsy; Endometrial cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms
• Other Study ID Numbers: 16HH3687 USS guided biopsy EC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No