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

NCT03207126CompletedNAINTERVENTIONAL

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 the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer will be assessed as an alternative to hysteroscopy guided biopsy.

Key Facts

Lead Sponsor

Imperial College London

Enrollment

Start Date

2017-06-13

Completion Date

2020-01-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Ultrasound guided biopsy

Conditions

Endometrial CancerEndometrial NeoplasmsEndometrial HyperplasiaEndometrial Polyp

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis

All samples taken using ultrasound guided biopsy were analysed by histology lab. If they had sufficient tissue to give a diagnosis (benign, pre-malignant or malignant) this was deemed successful. It is deemed successful if there was sufficient tissue to give a histological analysis. So overall there will be a percentage success rate (number of tissue samples sufficient/number of tissue samples taken). Each patient would have had one sample.

Time frame: 1.5 years

Secondary Outcomes

Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire

Visual analogue score will be given to patients post procedure to assess tolerability of the procedure. The full score scale ranges from 0 to 10 that means from no pain (0) to worst pain they ever had (10).

Time frame: 1.5 years

Locations

Queen Charlotte and Hammersmith Hospital, London, United Kingdom

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.