Endometrial Cancer, Endometrial Hyperplasia, Endometrial Neoplasms, Endometrial Polyp
Conditions
Keywords
Ultrasound, Biopsy, 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 the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer will be assessed 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.
Interventions
DIAGNOSTIC_TESTUltrasound 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
Sponsors
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Women offered and received ultrasound guided biopsy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis | 1.5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire | 1.5 years | 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women Needing Endometrial Biopsy All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first.
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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Women Needing Endometrial Biopsy | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 61 years | — |
| Number of participants providing a tissue sample | 9 Participants | — |
| Pain score | 7.5 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 10 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women Needing Endometrial Biopsy | Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis | 9 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women Needing Endometrial Biopsy | Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire | 7.5 score on a scale |