NCT05378152

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

Completed NA Last updated 23 April 2024

What this trial tests

NA trial testing Pipelle biopsy catheter in Postmenopausal Bleeding in 82 participants. Completed in 25 February 2024.

Timeline

24 September 2022

Primary endpoint
23 February 2024

25 February 2024

Quick facts

Lead sponsor	Royal College of Surgeons, Ireland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	82
Start date	24 September 2022
Primary completion	23 February 2024
Estimated completion	25 February 2024
Sites	1 location across Ireland

Drugs / interventions tested

• Pipelle biopsy catheter
• Sham procedure — full drug profile →

Conditions studied

• Postmenopausal Bleeding — all drugs for Postmenopausal Bleeding →
• Endometrial Cancer — all drugs for Endometrial Cancer →
• Endometrial Hyperplasia — all drugs for Endometrial Hyperplasia →

Sponsor

Royal College of Surgeons, Ireland

Who can join

Eligibility, female only, with Postmenopausal Bleeding or Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial.
   Tunney DE, Yambasu DS, Gyawali DI, Gaughan DE, et al · · 2025 · cited 1× · PMID 40669559 · DOI 10.1016/j.jmig.2025.07.007