Clinical trial NCT06694246: Improving Outpatient Endometrial Biopsy Results
Official title: Outpatient Endometrial Biopsy Results; a Quality Improvement Project.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Histopathology
Screening Tool
Techniques
Keywords: Pipelle
Endometrial biopsy
histopathology
endometrial sampling
screening
outpatient
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Al Adan Hospital Kuwait
First posted: 2024-11-19
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing outpatient endometrial sampling

Brief summary: 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.


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

Primary outcomes:
measure: Adequacy of the sampled endometrial specimen for histopathology diagnosis
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Adan hospital
state: Ahmadi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & Wilkins; 2013 Apr 8. Chapter 8
citation: 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.
citation: Williams PM, Gaddey HL. Endometrial Biopsy: Tips and Pitfalls. Am Fam Physician. 2020 May 1;101(9):551-556.
citation: Del Priore G. Office-based endometrial sampling procedures. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on November 28, 2024.)