Improving Outpatient Endometrial Biopsy Results

NCT06694246 | Recruiting

• 1 other identifier: QIP2
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Histopathology; Screening Tool; Techniques

Keywords

Pipelle; Endometrial biopsy; histopathology; endometrial sampling; screening; outpatient

Outcome Measures

Primary Outcomes (1)

• Adequacy of the sampled endometrial specimen for histopathology diagnosis

  six months

Interventions

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.

Eligibility Criteria

• Gender Eligibility Details: Endometrial biopsy for females with abnormal uterine bleeding
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing outpatient endometrial sampling

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Al Adan Hospital Kuwait: collaborator

Study Sites (1)

Adan hospital

Kuwait, Al Ahmadi, 47000, Kuwait

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & Wilkins; 2013 Apr 8. Chapter 8

  BACKGROUND

• 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.

  BACKGROUND

• Williams PM, Gaddey HL. Endometrial Biopsy: Tips and Pitfalls. Am Fam Physician. 2020 May 1;101(9):551-556.

  PMID: 32352730 BACKGROUND

• Del Priore G. Office-based endometrial sampling procedures. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on November 28, 2024.)

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial biopsy samples

MeSH Terms

Interventions

Analgesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

KU (1)