Clinical trial · Interventional
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?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Postmenopausal Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pipelle biopsy catheter | Device | — | UNRESOLVED |
| Sham procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pipelle biopsy
- description
- This group will undergo an endometrial biopsy performed using a Pipelle catheter in the usual manner performed according to the physician either with or without a speculum and with or without a tenaculum. Local anaesthetic block may or may not be used as per clinical judgement.
- interventionNames
- Device: Pipelle biopsy catheter
- type
- SHAM_COMPARATOR
- label
- No Pipelle biopsy
- description
- This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed.
- interventionNames
- Device: Sham procedure
Primary outcomes (3)
- measure
- Pain scores
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTunney DE, Yambasu DS, Gyawali DI, Gaughan DE, O'Dwyer DV, Harrity DC, Reidy DF, Ahmed DR, Molphy DZ, Asandei D, Salameh DF, Burke DN. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2025 Oct;32(10):914-920. doi: 10.1016/j.jmig.2025.07.007. Epub 2025 Jul 14. PMID 40669559