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

Not Applicable

Completed

• Conditions: Postmenopausal Bleeding; Endometrial Hyperplasia; Endometrial Cancer
• Interventions: Device: Pipelle biopsy catheter; Device: Sham procedure

• Registration Number: NCT05378152
• Lead Sponsor: Royal College of Surgeons, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-18
• Study Start: 2022-09-24
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pipelle biopsy	Pipelle biopsy catheter	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.
No Pipelle biopsy	Sham procedure	This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed.

Primary Outcome Measures

Name	Time	Method
Pain scores	Immediately after intervention, within 1 minute of carrying out intervention	Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain

Secondary Outcome Measures

Name	Time	Method
Cost saving	3 months	Cost saving between the two groups
Changes in follow up	3 months	Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances.,

Trial Locations

Locations (1)

Rotunda hospital; 🇮🇪 Dublin, Ireland