Brief Title
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?
Official Title
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy in the Detection of Endometrial Cancer?
Brief Summary
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.
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
Primary Outcome
Accuracy of histological diagnosis using ultrasound guided biopsy.
Secondary Outcome
Patient satisfaction of Ultrasound guided biopsy
Condition
Endometrial Cancer
Intervention
Ultrasound guided biopsy
Study Arms / Comparison Groups
Women needing endometrial biopsy
Description: All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
50
Start Date
June 13, 2017
Completion Date
January 1, 2021
Primary Completion Date
December 20, 2020
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 020 7589 5111, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03207126
Organization ID
16HH3687 USS guided biopsy EC
Responsible Party
Sponsor
Study Sponsor
Imperial College London
Study Sponsor
, ,
Verification Date
June 2020