NCT03115593

Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brugmann University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035. The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management. The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity. The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	Blind biopsy with a pipette	Patients willing to participate to the study will benefit from a double biopsy. The first biopsy will be a blind biopsy performed by aspiration with a Cornier pipette.
PROCEDURE	Targeted biopsy using hysteroscopy	During the same consultation, patients will benefit from a diagnostic hysteroscopy with vaginoscopy and saline (allowing a wash of the debris caused by the pipette biopsy), using a rigid hysteroscope of 4.3 mm equipped with an operator channel allowing the passage of a biopsy tong.

Timeline

• Start date: 2018-07-10
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2017-04-14
• Last updated: 2020-08-07

Locations

4 sites across 2 countries: Belgium, France