Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
Primary Purpose
Postmenopausal Bleeding, Endometrial Cancer, Endometrial Hyperplasia
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Pipelle biopsy catheter
Sham procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Postmenopausal Bleeding focused on measuring Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer
Eligibility Criteria
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
Sites / Locations
- Rotunda hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Pipelle biopsy
No Pipelle biopsy
Arm Description
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.
This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed.
Outcomes
Primary Outcome Measures
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Pain scores
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Secondary Outcome Measures
Cost saving
Cost saving between the two groups
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.,
Full Information
NCT ID
NCT05378152
First Posted
May 3, 2022
Last Updated
March 29, 2023
Sponsor
Royal College of Surgeons, Ireland
Collaborators
The Rotunda Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05378152
Brief Title
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
Official Title
Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
The Rotunda Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Bleeding, Endometrial Cancer, Endometrial Hyperplasia
Keywords
Postmenopausal bleeding, Ambulatory gynaecology, Endometrial sampling, Endometrial hyperplasia, Endometrial cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pipelle biopsy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Pipelle biopsy
Arm Type
Sham Comparator
Arm Description
This group will undergo a sham procedure where a speculum is inserted into the vagina and then removed.
Intervention Type
Device
Intervention Name(s)
Pipelle biopsy catheter
Intervention Description
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
Intervention Name(s)
Sham procedure
Intervention Description
A speculum is inserted into the vagina and then removed
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Time Frame
Immediately before procedure, less than 5 minutes prior to starting hysteroscopy
Title
Pain scores
Description
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Time Frame
Immediately after procedure, within 1 minute of finishing hysteroscopy
Title
Pain scores
Description
Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain
Time Frame
Immediately after intervention, within 1 minute of carrying out intervention
Secondary Outcome Measure Information:
Title
Cost saving
Description
Cost saving between the two groups
Time Frame
3 months
Title
Changes in follow up
Description
Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances.,
Time Frame
3 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liz Tunney
Phone
0851752436
Email
etunney@ROTUNDA.ie
Facility Information:
Facility Name
Rotunda hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Tunney
Phone
0851752436
Email
etunney@ROTUNDA.ie
12. IPD Sharing Statement
Learn more about this trial
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
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