Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
Sponsored by Royal College of Surgeons, Ireland
About this trial
Last updated 2 years ago
Study ID
REC-2021-025
Status
Recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
All
Female
Trial Timing
Ended 2 years ago
What is this trial about?
Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a
woman's last menstrual cycle. PMB represents one of the most common reasons for referral to
gynaecology services. Approximately 10% of women with PMB will be found to have endometrial
cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the
outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial
sampling.
Up to 60% of women that present with PMB will have an atrophic-appearing cavity at
hysteroscopy. This provides a challenge in obtaining a histological sample through both
dilatation & curretage (D&C) and Pipelle biopsy. Often, scant tissue that is insufficient for
clinical diagnosis is obtained.
Pipelle biopsy is associated with patient discomfort. It is also associated with costs
related to the purchasing of equipment and the processing of samples in the laboratory to the
sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic
cavity will return any clinically meaningful result. A negative hysteroscopy reduces the
probability of endometrial cancer to 0.6%.
This study aims to compare patients with PMB and atrophic-appearing cavity that undergo
pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences
in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients
with PMB and atrophic-appearing cavity.
What are the participation requirements?
Inclusion Criteria
- Postmenopausal
- Postmenopausal bleeding
- Tolerates hysteroscopy
Exclusion Criteria
- Premenopausal
- Any lesion requiring biopsy at time of hysteroscopy
- Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy
- History of endometrial hyperplasia/cancer
Locations
Location
Status
Recruiting