Clinical trial NCT05378152: Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
Official title: Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Bleeding
Endometrial Cancer
Endometrial Hyperplasia
Keywords: Postmenopausal bleeding
Ambulatory gynaecology
Endometrial sampling
Endometrial hyperplasia
Endometrial cancer
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: The Rotunda Hospital
First posted: 2022-05-18
Enrollment: 82
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain scores
timeFrame: Immediately before procedure, less than 5 minutes prior to starting hysteroscopy
measure: Pain scores
timeFrame: Immediately after procedure, within 1 minute of finishing hysteroscopy
measure: Pain scores
timeFrame: Immediately after intervention, within 1 minute of carrying out intervention
Secondary outcomes:
measure: Cost saving
timeFrame: 3 months
measure: Changes in follow up
timeFrame: 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Rotunda hospital
Study officials:
References: