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Completed

NCT Number: NCT05378152

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

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pipelle biopsy catheter

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 The internal piston will be withdrawn to create negative pressure.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.

Sham Procedure

Device

A speculum is inserted into the vagina and then removed

Primary outcomes

  1. Pain scores

    Time frame: Immediately before procedure, less than 5 minutes prior to starting hysteroscopy

    Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain

  2. Pain scores

    Time frame: Immediately after procedure, within 1 minute of finishing hysteroscopy

    Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain

  3. Pain scores

    Time frame: 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 outcomes

  1. Cost saving

    Time frame: 3 months

    Cost saving between the two groups

  2. Changes in follow up

    Time frame: 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.,

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • The Rotunda Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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