Recruiting NCT06694246

Improving Outpatient Endometrial Biopsy Results

— Observational Histopathology Screening Tool Techniques

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Improving technique, Using hysteroscopy in candidate patients, Analgesia.
Who it may be relevant to: Registry conditions: Histopathology, Screening Tool, Techniques. Basic parameters: No limits · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Kuwait
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Outpatient Endometrial Biopsy Results; a Quality Improvement Project.

Overview

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.

Interventions

Other Improving technique
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
Other Using hysteroscopy in candidate patients
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.
Other Analgesia
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 outcome measures

Adequacy of the sampled endometrial specimen for histopathology diagnosis [Time frame: six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Other

Study locations

Kuwait · 1 center

Adan hospital — Kuwait

Publications

Andrews B, Quick K, MacLeod E, Edwards K, Rone BK. Cervical bleeding with cervical stabilization during IUD placement: allis clamp versus single-tooth tenaculum, a randomized control trial. Arch Gynecol Obstet. 2023 Apr;307(4):1015-1019. doi: 10.1007/s00404-022-06784-x. Epub 2022 Dec 7. PMID 36477274
Sierecki AR, Gudipudi DK, Montemarano N, Del Priore G. Comparison of endometrial aspiration biopsy techniques: specimen adequacy. J Reprod Med. 2008 Oct;53(10):760-4. PMID 19004401
ACOG Committee Opinion No. 734: The Role of Transvaginal Ultrasonography in Evaluating the Endometrium of Women With Postmenopausal Bleeding. Obstet Gynecol. 2018 May;131(5):e124-e129. doi: 10.1097/AOG.0000000000002631. PMID 29683909
ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Obstet Gynecol. 2013 Apr;121(4):891-896. doi: 10.1097/01.AOG.0000428646.67925.9a. PMID 23635706
Terzic MM, Aimagambetova G, Terzic S, Norton M, Bapayeva G, Garzon S. Current role of Pipelle endometrial sampling in early diagnosis of endometrial cancer. Transl Cancer Res. 2020 Dec;9(12):7716-7724. doi: 10.21037/tcr.2020.04.20. PMID 35117374
Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & Wilkins; 2013 Apr 8. Chapter 8
Gallos ID, Alazzam M, Clark TJ, Faraj R, Rosenthal AN, Smith PP, Gupta JK. Management of endometrial hyperplasia. Green-top guideline no. 67. RCOG/BSGE Joint Guideline. 2016.
Williams PM, Gaddey HL. Endometrial Biopsy: Tips and Pitfalls. Am Fam Physician. 2020 May 1;101(9):551-556. PMID 32352730

Identifiers

NCT: NCT06694246 · QIP2

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗