N/A
N=10
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?
Endometrial Cancer · Endometrial Neoplasms · Endometrial Hyperplasia · Endometrial Polyp
Bottom Line
View on ClinicalTrials.gov: NCT03207126 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound guided biopsy (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis |
9 | — |
| SECONDARY Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire |
7.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03207126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.