An observational study in Histopathology, Screening Tool and Techniques, sponsored by Cairo University. Recruiting at 1 site in Kuwait. Open to female participants. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Cairo University · Observational
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.
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients undergoing outpatient endometrial sampling
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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.
Adequacy of the sampled endometrial specimen for histopathology diagnosis
Time frame: six months
Plan to share: Undecided — Patient confidentiality. It may be shared with reasonable request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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