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NCT Number: NCT06694246

Improving Outpatient Endometrial Biopsy Results

Pipelle is the most commonly used outpatient endometrial biopsy device. Pipelle endometrial biopsy can diagnose 90% of endometrial cancer cases. Pipelle endometrial biopsy is one of the first-line diagnostic procedures for women presenting with abnormal peri- and post-menopausal vaginal bleeding.

Insufficient samples are obtained in 5-23% of cases. In Adan Hospital, a retrospective analysis of all outpatient endometrial samples sent to the histopathology department from April- to October 2024 study showed an insufficient sample percentage of 32% This may be attributed to factors such as patients, equipment, and physicians.

This project aims to improve the endometrial biopsy results by Identifying these factors in the Adan hospital setting, Implementing measures to modify these factors, and finally re-auditing the endometrial biopsy results after six months.

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Key information

Conditions

Histopathology Screening Tool Techniques

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing outpatient endometrial biopsy in the specified time interval (11/2024- 4/2025) will be included.

Exclusion criteria

  • Could not obtain the sample due to patient physicals, anxiety (patient decline), cervical stenosis, or severe bleeding

Treatment and study plan

Improving technique

Other

A checklist was developed to ensure the important steps were followed, with tips for obtaining a more adequate sample. This checklist was put in the outpatient procedures room, and each physician performing a biopsy was asked to fill it out.

Also, a diagram containing illustrative images with the basic steps was put in the procedures room.

The topic was covered in the biweekly scientific meeting, and all factors attributed to the inadequate sample were discussed.

The department lead mentioned the topic in the OBGYN department's private messaging group.

It was finally mentioned in the morning meeting.

Using hysteroscopy in candidate patients

Other

Patients with focal lesions on ultrasound will undergo hysteroscopy and biopsy instead of blind endometrial sampling.

Patient with stenosed cervix or failed previous sampling might also undergo hysteroscopic guided biopsy.

Analgesia

Other

Analgesia in the form of paracetamol or NSAIDs might be given to some patients 30- 60 minutes before the procedure to reduce the procedure-associated pain and the resultant failure to complete it and obtain an adequate sample.

Primary outcomes

  1. Adequacy of the sampled endometrial specimen for histopathology diagnosis

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Al Adan Hospital Kuwait

Registry information

Official study title

Outpatient Endometrial Biopsy Results; a Quality Improvement Project.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Dec 4, 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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