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

Royal College of Surgeons, Ireland

Status: Completed

Conditions: Endometrial Cancer; Endometrial Hyperplasia; Postmenopausal Bleeding

Treatments: Device: Sham procedure; Device: Pipelle biopsy catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05378152

REC-2021-025

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Pipelle biopsy

Active Comparator group

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.

Treatment:

Device: Pipelle biopsy catheter

No Pipelle biopsy

Sham Comparator group

Description:

This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed.

Treatment:

Device: Sham procedure