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

Is Pipelle Biopsy of Benefit 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.

Study Overview

• Status: Completed
• Conditions: Endometrial Hyperplasia; Endometrial Cancer; Postmenopausal Bleeding
• Intervention / Treatment: Device: Pipelle biopsy catheter; Device: Sham procedure

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Rotunda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: The Rotunda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2022
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Endometrial cancer; Postmenopausal bleeding; Ambulatory gynaecology; Endometrial sampling; Endometrial hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemorrhage; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms; Uterine Hemorrhage
• Other Study ID Numbers: REC-2021-025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No