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

Study Overview
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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.

Official Title
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Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?

Conditions
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Postmenopausal Bleeding, Endometrial Cancer, Endometrial Hyperplasia

Intervention / Treatment
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* Device: Pipelle biopsy catheter
* Device: Sham procedure


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pipelle biopsy<br>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. | Device: Pipelle biopsy catheter<br>* 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.<br>|
| Sham Comparator: No Pipelle biopsy<br>This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed. | Device: Sham procedure<br>* A speculum is inserted into the vagina and then removed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately before procedure, less than 5 minutes prior to starting hysteroscopy | 
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately after procedure, within 1 minute of finishing hysteroscopy | 
| Pain scores | Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain | Immediately after intervention, within 1 minute of carrying out intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost saving | Cost saving between the two groups | 3 months | 
| Changes in follow up | Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances., | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer