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

NCT ID: NCT03115593

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2020-03-02

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

postmenopausal patients with metrorrhagia

Postmenopausal patients with metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result).

The threshold choice of 3 mm was chosen according to a recent review of the literature to limit the risk of false negatives for cancer.

Group Type: EXPERIMENTAL

Blind biopsy with a pipette

Intervention Type: PROCEDURE

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.

Targeted biopsy using hysteroscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• postmenopausal patient.
• patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)

Exclusion Criteria

• patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andre Nazac

Head of clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André Nazac, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Hôpitaux Iris Sud - Site Ixelles

Brussels, , Belgium

CHR Citadelle

Liège, , Belgium

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Countries

Belgium; France

Other Identifiers

CHUB-Hystocor

Identifier Type: -

Identifier Source: org_study_id