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

NCT05378152 | Completed

• 1 other identifier: REC-2021-025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Bleeding; Endometrial Cancer; Endometrial Hyperplasia

Keywords

Postmenopausal bleeding; Ambulatory gynaecology; Endometrial sampling; Endometrial hyperplasia; Endometrial cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Cost saving

  3 months

• Changes in follow up

  3 months

Study Arms (2)

Pipelle biopsy

ACTIVE COMPARATOR

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

No Pipelle biopsy

SHAM COMPARATOR

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

Device: Sham procedure

Interventions

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.

Pipelle biopsy

Sham procedure DEVICE

A speculum is inserted into the vagina and then removed

No Pipelle biopsy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal
• Postmenopausal bleeding
• Tolerates hysteroscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• The Rotunda Hospital: collaborator

Study Sites (1)

Rotunda hospital

Dublin, Ireland

Location

Related Publications (1)

• Tunney DE, Yambasu DS, Gyawali DI, Gaughan DE, O'Dwyer DV, Harrity DC, Reidy DF, Ahmed DR, Molphy DZ, Asandei D, Salameh DF, Burke DN. Endometrial Biopsy Versus No Endometrial Biopsy with a Normal-Appearing Cavity During In-office Hysteroscopy for Postmenopausal Bleeding: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2025 Oct;32(10):914-920. doi: 10.1016/j.jmig.2025.07.007. Epub 2025 Jul 14.

  PMID: 40669559 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 18, 2022
• Study Start: September 24, 2022
• Primary Completion: February 23, 2024
• Study Completion: February 25, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IE (1)