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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-24

Study Completion Date

2024-02-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Bleeding Endometrial Cancer Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pipelle biopsy

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.

Group Type ACTIVE_COMPARATOR

Pipelle biopsy catheter

Intervention Type DEVICE

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.

No Pipelle biopsy

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

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type DEVICE

A speculum is inserted into the vagina and then removed

Interventions

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Pipelle 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.

Intervention Type DEVICE

Sham procedure

A speculum is inserted into the vagina and then removed

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes