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AzTrials

HistopathologyNCT06694246

Improving Outpatient Endometrial Biopsy Results

An observational study of Histopathology and Screening Tool, run by Cairo University at 1 site in Kuwait.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Histopathology, Screening Tool, Techniques
What is being tested?
Improving technique, Using hysteroscopy in candidate patients and Analgesia
How many people
400 participants
Where
1 siteKuwait
Study dates
1 Nov 2024to 30 Apr 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients undergoing outpatient endometrial sampling

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kuwait1 site, 1 recruiting

  • Adan hospital

    Kuwait, Al Ahmadi, 47000

    Tarek, +965-99780408, tarekelkhatib1952@gmail.com

    Recruiting

Other trials in Kuwait

About this study

Official title: Outpatient Endometrial Biopsy Results; a Quality Improvement Project.

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.

Being tested
Improving technique, Using hysteroscopy in candidate patients, Analgesia
Keywords
Pipelle, Endometrial biopsy, histopathology, endometrial sampling, screening, outpatient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improving techniqueOther

    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 patientsOther

    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.

  • AnalgesiaOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adequacy of the sampled endometrial specimen for histopathology diagnosis

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start1 Nov 2024
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694246
Sponsor's protocol ID
QIP2
Status last verified
Dec 2024
First submitted
15 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Patient confidentiality. It may be shared with reasonable request.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32352730

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

Questions about this trial

What is this clinical trial studying?

An observational study of Histopathology and Screening Tool, run by Cairo University at 1 site in Kuwait.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequacy of the sampled endometrial specimen for histopathology diagnosis (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694246, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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