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Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity

Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05378152
Enrollment
82
Registered
2022-05-18
Start date
2022-09-24
Completion date
2024-02-25
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Endometrial Hyperplasia, Postmenopausal Bleeding

Keywords

Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer

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.

Interventions

DEVICEPipelle biopsy catheter

A speculum will be inserted into the vagina. A Pipelle biopsy catheter will be inserted through the cervix up to the fundus of the uterus. The internal piston will be withdrawn to create negative pressure. The catheter will be moved back and forth and rotated to collect the biopsy. The catheter will then be removed, followed by the speculum. The sample will be sent to the laboratory for assessment.

DEVICESham procedure

A speculum is inserted into the vagina and then removed

Sponsors

The Rotunda Hospital
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoresImmediately before procedure, less than 5 minutes prior to starting hysteroscopyPain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain

Secondary

MeasureTime frameDescription
Cost saving3 monthsCost saving between the two groups
Changes in follow up3 monthsChanges in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances.,

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026